MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC HF CATHETER 5F MAXIMAL BARRIER TRAY (TRIPLE-LUMEN); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/07/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of rebx0608 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that after placement, it was observed that what appears to be a "remanence" of a guidewire was left in patient.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, trend 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 damaged guidewire was confirmed; however, the root cause was not identified.The product returned for evaluation was nine photographs which depicted a guidewire and a powerpicc catheter.Usage residues were visible in all nine photographs.Photograph 1, 2, 3, 6, 7, 8 and 9 depicted a guidewire that exhibited a knot approximately midway along its length.One tip of the guidewire exhibited a break.Slight elongation of the coil wire was observed.Photographs 4, 5 and 6 depicted a 5fr t/l powerpicc catheter.No catheter damage was evident in the photographs.While guidewire damage was evident in the supplied photographs, inspection of those photographs was insufficient to identify the cause of the damage.Potential contributing factors include tensile (pulling) stress and guidewire withdrawal against the introducer needle bevel.A lot history review (lhr) of rebx0608 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that after placement, it was observed that what appears to be a "remanence" of a guidewire was left in patient.

• Brand Name: POWERPICC HF CATHETER 5F MAXIMAL BARRIER TRAY (TRIPLE-LUMEN)
• 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: 8237019
• Report Number: 3006260740-2018-03851
• Device Sequence Number: 13848711
• Product Code: LJS
• UDI-Device Identifier: 00801741028175
• UDI-Public: (01)00801741028175
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2019
• Report Date (Section F): 12/20/2018

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 3385108QD
• Device Lot Number: REBX0608
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2019
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/07/2018
• Event Location: Hospital
• Date Report to Manufacturer: 12/17/2018
• Initial Date Received by Manufacturer: 12/17/2018
• Supplement Date Received by Manufacturer: 02/05/2019
• Initial Report FDA Received Date: 01/10/2019
• Supplement Report FDA Received Date: 02/20/2019
• 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: Required Intervention
• Patient Age: 83 YR
• Patient Weight: 82
• Date Report Sent to FDA: 12/20/2018