MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPORT TITANIUM ISP 6CF INT WSP ATT SL; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number 8706060

Device Problems Difficult to Flush (1251); Fracture (1260); Material Separation (1562); Suction Problem (2170); Failure to Infuse (2340); Migration (4003)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/30/2021

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history record is currently being performed.The device has not been returned to the manufacturer for evaluation.However, images were provided for review.The investigation of the reported event is currently underway.(expiry date: 07/2022).

Event Description

It was reported that post port placement procedure via right internal jugular vein, the infusion used in patient allegedly failed.It was further reported that the distal end of the catheter allegedly migrated to the atrium.Reportedly blood aspiration failed.The procedure was completed by using anaesthesia.The patient was reportedly stabilized.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: the sample was not returned for evaluation; however, three medical images were provided for review.The investigation is inconclusive for the reported suction and flushing issue as the exact circumstances at the time of reported event is unknown and clinical conditions cannot be replicated to confirm these failures.However, the investigation is confirmed for the reported fracture, migration and material separation issue as the anterior-posterior view shows a right sided port and catheter attached proximally.Furthermore, the catheter travels above the right clavicle then downward towards the right heart and another object resembling a catheter is seen coursing above the left clavicle.The definitive root cause could not be determined based upon available 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 instructions for use reviewed and it states that, "this device is contraindicated for catheter insertion in the subclavian vein medial to the border of the first rib, an area which is associated with higher rates of pinch-off." ¿signs of pinch-off clinical: ¿ difficulty with blood withdrawal, ¿ resistance to infusion of fluids, ¿ patient position changes required for infusion of fluids or blood withdrawal.Radiologic: ¿ grade 1 or 2 distortion on chest x-ray.Pinch-off should be evaluated for degree of severity prior to explantation.Patients indicating any degree of catheter distortion at the clavicle/first rib area should be followed diligently.There are grades of pinch-off that should be recognized with appropriate chest x-ray as follows¿ ¿preventing pinch-off the risk of pinch-off syndrome can be avoided by inserting the catheter via the internal jugular vein (ij).Subclavian insertion of the catheter medial to the border of the first rib may cause catheter pinch-off, which in turn results in occlusion causing port system failure during power injection.If you choose to insert the catheter into the subclavian vein, it should be inserted lateral to the border of the first rib or at the junction with the axillary vein because such insertion will avoid compression of the catheter, which can cause damage and even sever the catheter.The use of image guidance upon insertion is strongly recommended.A radiographic confirmation of catheter insertion should be made to ensure that the catheter is not being pinched.¿ h10: d4 (expiry date: 07/2022).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.

Event Description

It was reported that post port placement procedure via right internal jugular vein, the infusion used in patient allegedly failed.It was further reported that the distal end of the catheter allegedly fractured, separated and migrated to the atrium.Reportedly blood aspiration failed.The port was removed from the right chest wall under local anesthesia.The patient was reportedly stabilized.

• Brand Name: POWERPORT TITANIUM ISP 6CF INT WSP ATT SL
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 12587448
• MDR Text Key: 275131105
• Report Number: 3006260740-2021-04169
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741098871
• UDI-Public: (01)00801741098871
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K072549
• 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
• Report Date: 10/27/2021

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: 8706060
• Device Lot Number: REEV2610
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/10/2021
• Initial Date FDA Received: 10/07/2021
• Supplement Dates Manufacturer Received: 12/10/2021
• Supplement Dates FDA Received: 12/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 75 KG