MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 4F SL POWERPICC SOLO WITH 3CG TPS; PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER

Catalog Number 2194108

Device Problems Difficult To Position (1467); Malposition of Device (2616)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/18/2017

Event Type  Injury  

Manufacturer Narrative

The information provided by bard 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 bard.The device has not been returned to the manufacturer, at this time, for evaluation.A lot history review (lhr) of rebn2183 showed no other similar product complaint(s) from this lot number.

Event Description

Facility reported difficulty placing the picc line.The healthcare professional (hcp) attempted to place the picc and stated the placement was ¿dysfunctional¿.The hcp attempted to remove the picc and was unsuccessful, taulock was tried 3 times, then naci 20 ml without aspiration.The hcp tried heating up the arm to manipulate the picc out, but only 18 cm came out.Ultrasound was done and confirmed picc placement in the vein, without signs of thrombosis.The guidewire went in easily, but the picc line disappears into the patient¿s arm.An x-ray of the thorax, picc confirmed.The reported event required surgical removal and a new catheter was placed requiring new vessel access.

Manufacturer Narrative

The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of a picc migrating in the patient is confirmed based on the description of the event and the returned sample.The complaint is found to be use-related, while other considerations may have contributed.The sample returned consisted of two segments of a 4 fr s/l powerpicc solo.Visual observation found that the catheter was returned in two pieces which appeared to fit together.The proximal piece contained the extension leg, solo valve, securement wings, and catheter until just distal to the 9-cm depth mark.The second segment of catheter clearly contained the 10- through 21-cm depth marks, and very worn 22- and 23-cm depth marks.The 24-cm depth mark may have been present based on the estimated position, but it was not visible.This distal end of the catheter terminated in a crimp, with marks suggesting clamping with a jawed metal instrument such as hemostats; this is confirmed by follow-up, showing that the catheter was clamped just before the catheter broke off and embolized at the clamping point.Just before this point, a large hole in the catheter was found which appeared highly irregular and which formed a rough ¿c¿ shape, with the arc pointing proximally.The 0-cm depth mark was also somewhat worn.The extension leg and proximal portion of catheter manifested some residue appearing to be adhesive.Tactual evaluation found both segments of catheter manifested tensile weakness.Microscopic observation found the distal end of the proximal segment to be smooth and striated, typical of sharp instrument damage.Residue was found on the proximal end of the distal segment, and somewhat within the lumen.The edge was well defined.The hole near the crimped distal end of the distal segment was found to be adjacent to another hole, roughly transverse.Both of these holes, as well as the cracks/holes apparently occasioned by the crimping near the tip, were very irregular.Some granular fracture surfaces were noted.Although it is known the clamping contributed to the hole, and presumably the tension on the catheter during attempted removal, the appearance of the holes is unusual and may indicate unknown material alteration, such as from chemical exposure.The original report of difficulty of removal, along with loss of catheter function, may be related to the formation of a fibrin sheath/tail, which may both block the catheter from infusion and/or aspiration and adhere the catheter to the vessel wall.No further action is required because the reported event could not be related to a deficiency in product manufacture or deficiency while under correct product use.The ifu warns against use of or excessive exposure to certain materials: alcohol, acetone, and polyethylene glycol.In addition, mechanical damage to the catheter material is also warned against.In addition, fibrin sheath formation is a known complication with this product.

Event Description

Facility reported difficulty placing the picc line.The healthcare professional (hcp) attempted to place the picc and stated the placement was ¿dysfunctional¿.The hcp attempted to remove the picc and was unsuccessful, taulock was tried 3 times, then nacl 20 ml without aspiration.The hcp tried heating up the arm to manipulate the picc out, but only 18 cm came out.Ultrasound was done and confirmed picc placement in the vein, without signs of thrombosis.The guidewire went in easily, but the picc line disappears into the patient¿s arm.An x-ray of the thorax, picc confirmed.The reported event required surgical removal and a new catheter was placed requiring new vessel access.

• Brand Name: 4F SL POWERPICC SOLO WITH 3CG TPS
• Type of Device: PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer Contact: teresa johnson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225435
• MDR Report Key: 6746701
• MDR Text Key: 81149026
• Report Number: 3006260740-2017-01140
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741139055
• UDI-Public: (01)00801741139055
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K072230
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/01/2017

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2018
• Device Catalogue Number: 2194108
• Device Lot Number: REBN2183
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/27/2017
• Supplement Dates Manufacturer Received: 10/09/2017
• Supplement Dates FDA Received: 11/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2017
• 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): Required Intervention