MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SOLO 5F DL 135CM NITINOL GUIDEWIRE; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	3295335
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of reeu1427 showed three other similar product complaint(s) from this lot number.The complaints for this lot number have been reported from the same facility in (b)(6).
Event or Problem Description
It was reported that during a procedure, three (3) piccs were used due to the guidewire constantly kinking, not being able to thread through the vein, and one wire came off and unravelled.This report addresses the third device.

• Brand Name: POWERPICC SOLO 5F DL 135CM NITINOL GUIDEWIRE
• 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: 11349383
• Report Number: 3006260740-2021-00395
• Device Sequence Number: 4568005
• Product Code: LJS
• UDI-Device Identifier: 00801741028120
• UDI-Public: (01)00801741028120
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K072230
• 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): 02/19/2021

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: 3295335
• Device Catalogue Number: 3295335
• Device Lot Number: REEU1427
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/26/2021
• Initial Report FDA Received Date: 02/19/2021
• 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