MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPORT ISP M.R.I. IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number 9808560

Device Problems Fracture (1260); Material Separation (1562); Deformation Due to Compressive Stress (2889); Naturally Worn (2988)

Patient Problems Swelling (2091); Swelling/ Edema (4577)

Event Date 09/02/2020

Event Type  Injury  

Manufacturer Narrative

The lot number for the device was provided.The device history records are currently under review.The return of the sample is pending.The investigation is currently underway.Medical device - expiry date: 03/2021.Device anticipated to be returned to the manufacturer.

Event Description

It was reported that post port implant in the internal jugular vein, the patient allegedly experienced swelling during flushing.It was further reported that the catheter was found broken and the distal segment removed.Reportedly, the port body was removed.The patient status is unknown.

Manufacturer Narrative

H10: manufacturing review: 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 device with a catheter in two segments were returned for evaluation.Functional, gross visual and microscopic visual were performed.A kink was noted on the proximal catheter segment.A circumferential split was noted approximately 9.8 cm from the distal end of the cath-lock.A complete circumferential break was noted approximately 10.9 cm from the distal end of the cath-lock.The distal segment measured approximately 13.4 cm in length.A circumferential split was noted 5 mm from the proximal end of the distal segment.The investigation is confirmed for the reported catheter break and the identified material separation, deformation and worn issue, as a circumferential split and a complete circumferential break was noted to the catheter.Both the edges of the complete circumferential break and split were rounded and jagged.The identified break is typical of flexural fatigue, which is due to the repetitive, cyclic kinking of the catheter.A definitive root cause for the reported failure 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.H10: (expiry date: 03/2021).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.

Event Description

It was reported that approximately two years post port implant in the internal jugular vein, the patient allegedly experienced swelling during flushing.It was further reported that the catheter was found broken and the distal segment removed.Reportedly, the port body was removed.The patient status is unknown.

• Brand Name: POWERPORT ISP M.R.I. IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 8F
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city UT 84116
• MDR Report Key: 10642679
• MDR Text Key: 210213495
• Report Number: 3006260740-2020-20000
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741027512
• UDI-Public: (01)00801741027512
• Combination Product (y/n): N
• PMA/PMN Number: K063377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9808560
• Device Catalogue Number: 9808560
• Device Lot Number: RECN2043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2020
• Date Manufacturer Received: 03/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other