MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 BROVIAC CV CATHETER, SINGLE-LUMEN, 6.6F; CHRONIC CATHETERS

Catalog Number 0600540CE

Device Problem Suction Problem (2170)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 06/17/2022

Event Type  Death  

Manufacturer Narrative

The catalog number identified has not been cleared in the us but is similar to the broviac cv catheter, single-lumen, 6.6f products that are cleared in the us.The pro code and 510 k number for the broviac cv catheter, single-lumen, 6.6f products are identified in procode and date received by manufacturer.As the lot number for the device was provided, a review of the device history records was performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.(expiration date: 07/2026).

Event Description

It was reported that following a chronic catheter placement procedure for leukemia treatment, the catheter was allegedly unable to aspirate blood.As a result, the device was removed.During removal of the device it was reported that life-threatening bleeding was observed.Allegedly, the patient was unable to be stabilized and expired.Reportedly, the local police/authorities have confiscated the catheter and insertion set.The products are being retained for their criminal investigation.

Event Description

It was reported that following a chronic catheter placement procedure for leukemia treatment, the catheter was allegedly unable to aspirate blood.As a result, the device was removed.During removal of the device it was reported that life-threatening bleeding was observed.Allegedly, the patient was unable to be stabilized and expired.Reportedly, the local police/authorities have confiscated the catheter and insertion set.The products are being retained for their criminal investigation.

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the broviac cv catheter, single-lumen, 6.6f products that are cleared in the us.The pro code and 510 k number for the bbroviac cv catheter, single-lumen, 6.6f products are identified in d2 and g4.Manufacturing review: this is the only complaint reported to date for this product and lot.However, due to the severity of this event, a dhr review was requested.The device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing-related cause for this event.Investigation summary: the physical device was not returned for evaluation.No photo samples were provided for review.Therefore, the investigation is inconclusive for the reported bleeding and aspiration issues as no objective evidence that could be used for confirmation was provided for review.A definitive root cause for the bleeding and aspiration issues could not be determined based upon the provided information.It is unknown whether patient and/or procedural issues contributed to the reported event, including whether the observed bleeding was caused during placement.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : device not returned.

Event Description

It was reported that following a chronic catheter placement procedure for leukemia treatment, the catheter was allegedly unable to aspirate blood.As a result, the device was removed.During removal of the device it was reported that life-threatening bleeding was observed.Allegedly, the patient was unable to be stabilized and expired.Reportedly, the local police/authorities have confiscated the catheter and insertion set.The products are being retained for their criminal investigation.

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the broviac cv catheter, single-lumen, 6.6f products that are cleared in the us.The pro code and 510 k number for the bbroviac cv catheter, single-lumen, 6.6f products are identified in d2 and g4.H10: manufacturing review: this is the only complaint reported to date for this product and lot.However, due to the severity of this event, a dhr review was requested.The device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing-related cause for this event.Investigation summary: one broviac s/l catheter, one j-tip guidewire, one fully peeled 7.0fr peel-apart sheath and one vessel dilator were received for evaluation.The sample appeared to have residue throughout.The tissue cuff was intact and had residue.The j-tip guidewire and the vessel dilator were noted to be bent throughout.Bends and twists were noted throughout both peeled apart sheath shafts.Under microscopic observation, the matted tissue cuff was noted to have fiber disturbance throughout.Some areas were noted to be missing the tissue cuff material.Residue was noted throughout.No abnormal elasticity or fractures were found throughout the catheter.Aspiration and infusion attempts were successful, and thrombus was observed exiting the distal end of the catheter.No leaks were observed in either test.The guidewire outer diameter measured within specification.No deformities to either end of the guidewire were identified, but residue was identified at the j-tip.The edges of the distal termination of the catheter were noted to be uneven.The surface was granular. no deformation was identified to the distal end of the sheath halves.The distal tip of the vessel dilator showed very slight deformities around the edge.The investigation cannot confirm the reported bleeding, patient death, and aspiration difficulty with the available information.A definitive root cause for the bleeding, patient death, and aspiration difficulty could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.The following extracts from this instruction for use may be useful/applicable given that limited information has been provided about the procedures surrounding this event.¿contraindications the device is contraindicated whenever: the patient¿s body size is insufficient to accommodate the size of the implanted device.Previous episodes of venous thrombosis or vascular surgical procedures at the prospective placement site.Local tissue factors will prevent proper device stabilization and/or access.¿ ¿warnings avoid vessel perforation.If the artery is entered, withdraw the needle and apply manual pressure for several minutes.If the pleural space is entered, withdraw the needle and evaluate patient for possible pneumothorax.¿ ¿cautions: when tunneling, the catheter must not be forced.Do not insert guidewire beyond the bevel of the needle while removing straightener from the needle hub in order to prevent guidewire damage or shearing.If the guidewire must be withdrawn while the needle is inserted, remove both the needle and guidewire as a unit to help prevent the needle from damaging or shearing the guidewire.¿ ¿precautions: i.Prior to beginning placement procedure, do the following: when using an introducer kit, verify that the catheter fits easily through the introducer sheath.Ii.To avert device damage and/or patient injury during placement: when using percutaneous introducers: carefully insert the introducer and catheter to avoid inadvertent penetration to vital structures in the thorax.To avoid blood vessel damage, do not allow the percutaneous introducer sheath to remain indwelling in the blood vessel without the internal support of a catheter or dilator.Simultaneously advance the sheath and dilator with rotational motion to help prevent sheath damage.¿ ¿possible complications the use of an indwelling central venous catheter provides an important means of venous access for critically ill patients; however, the potential exists for serious complications including the following: bleeding, hemothorax, laceration of vessels or viscus, myocardial erosion, perforation of vessels or viscus, vessel erosion, risks normally associated with local and general anesthesia, surgery, and post-operative recovery¿, ¿single lumen catheters: create subcutaneous tunnel from venous entrance site to skin exit site using tunneler or long forceps.C.Pull the catheter up through the tunnel to the venous entry site.(initial resistance may be felt as the surecuff* tissue ingrowth cuff or vitacuff* antimicrobial cuff first enters the tunnel.) gently holding the catheter proximal to the cuff while pulling the tunneler and catheter through the subcutaneous tunnel should result in smooth passage of the cuff into the tunnel.Caution: when tunneling, the catheter must not be forced.¿ ¿section d: percutaneous technique: 5.Straighten ¿j ¿ tip of guidewire with tip straightener and insert tapered end of tip straightener into the needle.Tip straightener should not be advanced over the guidewire beyond the guidewire tip.Caution: do not insert guidewire beyond the bevel of the needle while removing straightener from the needle hub in order to prevent guidewire damage or shearing.Remove the tip straightener and advance the guidewire into the superior vena cava.Advance the guidewire as far as appropriate for the procedure.Verify correct positioning radiographically.6.Gently withdraw and remove needle.Caution: if the guidewire must be withdrawn while the needle is inserted, remove both the needle and guidewire as a unit to help prevent the needle from damaging or shearing the guidewire.8.Make a small (approx.1 cm wide) incision parallel to the clavicle, positioning the guidewire at the center of the incision to permit proper entry of vessel dilator and sheath introducer.¿ ¿peel-apart sheath introducer instructions: 16.Advance the vessel dilator and sheath introducer as a unit over the exposed guidewire using a rotational motion.Advance it into the subclavian vein as a unit, leaving at least 2 cms of sheath exposed.Warning: avoid vessel perforation.¿ ¿after tissue grows into the surecuff* tissue ingrowth cuff (2 to 3 weeks), catheters can be removed from the subcutaneous tunnel using one of several methods.The method used will depend upon physician preference and the amount of tissue/cuff ingrowth that is present.The catheter can usually be removed by traction on the external segment (see #1 below) if it is not sutured internally at the cuff or vessel insertion site.Surgical removal (see #2 below) may be necessary to prevent breaking the catheter if the catheter does not dislodge easily with traction or if there is no definite suture site information.Warning: you should not feel any resistance when withdrawing the catheter from the vein.If you do encounter resistance, this may indicate that the catheter is being pinched between the clavicle and first rib (the ¿pinch-off¿ sign).Do not continue pulling against resistance as this may cause catheter breakage and embolism.Free up the resistance (e.G.By repositioning the patient) before proceeding further.1.Traction removal: pull the catheter external segment downward in a straight line away from the exit site with a series of gentle tugs.When separation of the cuff from the surrounding tissue and/or catheter occurs, there will be a ¿break-away¿ feeling.Continue to pull gently on the catheter to complete the removal.Apply pressure to the catheter/vein insertion site as needed to control bleeding.If the cuff remains in the subcutaneous tissue, dissect it out through a small incision utilizing local anesthesia.2.Surgical removal (using aseptic technique): a) locate the position of the cuff either by palpation or by observing the position of ¿dimpling¿ when traction is applied to the catheter¿s external segment.B) make a short transverse incision at or below the external side of the cuff taking care not to transect the catheter.Reach under the catheter with a curved, smooth-jawed clamp and pull up on the catheter to remove the catheter tip from the vein.Caution: do not grasp the catheter with any instrument that might sever or damage the catheter.C) dissect out the cuff.Transect the catheter on the exterior side of the cuff and remove the interior portion of the catheter and cuff through the incision.Caution: do not cut the catheter before removal from vein to avoid catheter embolism.D) remove the exterior segment of the catheter by pulling it from the skin exit site.E) apply pressure to the catheter/vein insertion site as needed to control bleeding.F) close the incision with a suture as needed.Apply antibiotic ointment to incision and skin exit sites and an occlusive dressing to prevent air embolism through the tract." h10: d4 (expiry date: 07/2026).H11: section a through f: the information provide by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : see h10.

• Brand Name: BROVIAC CV CATHETER, SINGLE-LUMEN, 6.6F
• Type of Device: CHRONIC CATHETERS
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 15142996
• MDR Text Key: 297028012
• Report Number: 3006260740-2022-03006
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K830256
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0600540CE
• Device Lot Number: HUFZ1533
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/08/2022
• Initial Date FDA Received: 08/01/2022
• Supplement Dates Manufacturer Received: 09/14/2022; 10/15/2023
• Supplement Dates FDA Received: 09/15/2022; 10/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 4 YR
• Patient Sex: Male