MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC FT CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET 5F; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation, as the device was discarded after the event occurred.A lot history review (lhr) of recr2486 showed no other similar product complaint(s) from this lot number.[mw5080576 rga 1266317.Pdf].
Event or Problem Description
Per medwatch: "patient had d/l powerpicc inserted on (b)(6) 2018.On (b)(6) 2018 the device started to leak under the dressing and was replaced on (b)(6) 2018.Each lumen was allegedly found to be leaking close to the hub from perforations in the catheter.".
Additional 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 leak is confirmed and was determined to be use related.One 5 fr dual lumen powerpicc ft was returned for evaluation.An initial visual observation showed the catheter was returned in two segments and use residue was observed throughout the sample.Both lumens of the catheter were flushed and pressurized with a 12 ml syringe of water and leakage was observed 2 mm distal to the bifurcation in both lumens.A microscopic observation revealed a small hole in the red lumen at the location of the leak.The sample was dissected and rough and uneven circumferential cracks were observed emanating from the small hole.This crack spanned the entire width of the inner wall of the red lumen and into part of the catheter septum.The catheter material around the hole was observed to be lighter in color on the outer wall and was duller in luster on the inner walls than the surrounding material.Indentations were observed on the side of the outer wall of the catheter adjacent to the small hole, and the catheter was observed to kink easily at this location.The investigation findings are consistent with material fatigue likely caused by prolonged and/or cyclic kinking of the catheter.This type of material fatigue can occur due to physiological, placement, usage, and mechanical factors that allow the catheter to become kinked and gradually form a crack in the catheter.The product ifu states: ¿avoid placement or securement of the catheter where kinking may occur, to minimize stress on the catheter, patency problems or patient discomfort.¿ an examination of the catheter structure revealed no potential damage/defect related to manufacture of the product.A lot history review (lhr) of recr2486 showed no other similar product complaint(s) from this lot number.[mw5080576 rga 1266317.Pdf].
Event or Problem Description
Per medwatch: "patient had d/l powerpicc inserted on (b)(6) 2018.On (b)(6) 2018 the device started to leak under the dressing and was replaced on (b)(6) 2018.Each lumen was allegedly found to be leaking close to the hub from perforations in the catheter.".

• Brand Name: POWERPICC FT CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET 5F
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8111556
• Report Number: 3006260740-2018-03420
• Device Sequence Number: 11205108
• Product Code: LJS
• UDI-Device Identifier: 00801741034565
• UDI-Public: (01)00801741034565
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2019
• Report Date (Section F): 10/11/2018

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 Model Number: N/A
• Device Catalogue Number: 1275108F
• Device Lot Number: RECR2486
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2018
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/11/2018
• Event Location: Hospital
• Date Report to Manufacturer: 11/06/2018
• Initial Date Received by Manufacturer: 11/06/2018
• Supplement Date Received by Manufacturer: 01/04/2018
• Initial Report FDA Received Date: 11/28/2018
• Supplement Report FDA Received Date: 01/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 10/11/2018