MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SOLO PROVENA CATHETER, 5F TL, 3CG; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	CK000291C
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample evaluation, applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of a kinked stylet wire was confirmed.The product returned for evaluation was a 5fr t/l powerpicc provena solo picc catheter and associated 3cg stylet.The stylet was returned withdrawn from the catheter and the stylet contained two kinks within the magnet tip: 4.4cm and 5.7cm from the distal tip.The stylet was also kinked about the proximal edge of the t-lock assembly which would have resulted in approximately 61.9cm of dwell length within the catheter.The associated catheter length was measured to be 62.1cm.The condition of the catheter was unremarkable as no potential damage, defect, or deformity was observed.The sample did contain light traces of a dark red substance consistent with dried blood residue.Outside the two kinks in the stylet, the stylet itself was unremarkable to gross visual evaluation.The inner conductive wire contained a sharp kink at that site and the angle of kink was consistent with a kink event involving an angle more than 140°.The condition of each magnet within the magnet string was unremarkable.The observed kink damage likely occurred due to prolapsing (a sharp kink of the catheter/wire assembly) of the stylet wire within the patient during insertion.This is also consistent with the event description reported by the complainant facility, ¿wire bent while trying to cross the shoulder.Couldn¿t¿ get wire to cross and it was pulled out of the patient¿.No potential manufacture deficiency was observed during evaluation of the returned device.A lot history review (lhr) of rees1322 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported unable to get wire to cross the shoulder during insertion.The wire was pulled out of the patient and a bend in the wire was noticed.On (b)(6) 2020: during device evaluation the wire was found to be kinked.

• Brand Name: POWERPICC SOLO PROVENA CATHETER, 5F TL, 3CG
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 11205379
• Report Number: 3006260740-2020-21394
• Device Sequence Number: 19794908
• Product Code: LJS
• UDI-Device Identifier: 00801741161162
• UDI-Public: (01)00801741161162
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K053501
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: CK000291C
• Device Catalogue Number: CK000291C
• Device Lot Number: REES1322
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/30/2020
• Initial Report FDA Received Date: 01/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other