MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC 5F DUAL-LUMEN POLYURETHANE CATHETER RADIOLOGY BASIC TRAY (135 CM NITIN; 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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a damaged guidewire was confirmed and the cause appeared to be use-related.The product returned for evaluation was one 135cm nitinol guidewire.Usage residues were observed throughout the sample.A coil misalignment was observed within the coil region.The weld tip was intact.Tactile inspection of the sample confirmed that the core wire was intact.Microscopic inspection of the sample confirmed misalignment of the coil wire near the weld tip.The coil misalignment was consistent with device manipulation.The blood residue suggested that manipulation occurred during attempted device use.Such misalignment can occur of wire advancement is attempted into tissue or through a tortuous path.A lot history review (lhr) of recx2376 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the guidewire that comes with the powerpicc was defective.It was stated the tip had a break/fracture in the connection and the guidewire would not advance through the access needle.

• Brand Name: POWERPICC 5F DUAL-LUMEN POLYURETHANE CATHETER RADIOLOGY BASIC TRAY (135 CM NITIN
• 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: 8676000
• Report Number: 3006260740-2019-01573
• Device Sequence Number: 11260894
• Product Code: LJS
• UDI-Device Identifier: 00801741027949
• UDI-Public: (01)00801741027949
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K051672
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/06/2019

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: 3275335
• Device Lot Number: RECX2376
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2019
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2019
• Initial Report FDA Received Date: 06/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1