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)
Date of Event	06/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of recx3590 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the guidewire within the hoop was kinked in two places, not allowing the wire to be threaded through the needle.A new kit was opened to complete the procedure.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, complaint and lot history review, applicable previous investigation(s), sample (if available), labeling, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a kinked guidewire is confirmed; however, the exact cause is unknown.One 0.018 in.Nitinol guidewire in a plastic hoop was returned for evaluation.An initial visual observation showed a clear fluid within the hoop.Two kinks were observed in the coiled wire of the guidewire approximately 1.5 cm and 2.9 cm proximal to its distal tip.A microscopic observation revealed the coiled wire of the guidewire was kinked but unbroken, and weld tip was observed to be present and intact.No observations were made which indicated a root cause to the event.While the exact cause of the kinks in the guidewire could not be determined, it is possible the guidewire was damage during packaging, manipulation, or attempted use.A lot history review (lhr) of recx3590 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the guidewire within the hoop was kinked in two places, not allowing the wire to be threaded through the needle.A new kit was opened to complete the procedure.

• 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: 8776685
• Report Number: 3006260740-2019-01896
• Device Sequence Number: 1904603
• Product Code: LJS
• UDI-Device Identifier: 00801741027949
• UDI-Public: (01)00801741027949
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K051672
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2019

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: RECX3590
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 06/17/2019
• Supplement Date Received by Manufacturer: 07/22/2019
• Initial Report FDA Received Date: 07/10/2019
• Supplement Report FDA Received Date: 08/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1