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
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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 the guide wire came off and unravelled.No patient injury was reported.
Additional Manufacturer Narrative
H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The following were reviewed as part of this investigation: patient severity, complaint and lot history review, applicable previous investigation(s), sample (if available), labeling, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a damaged guidewire is confirmed.One 0.018 in.Nitinol guidewire was returned for evaluation.An initial visual observation showed use residue on the returned sample.The core wire of the guidewire was observed to be broken, the coiled wire was found to be unraveled, and the distal end of the guidewire was observed to be knotted.A microscopic observation revealed the coils of the knotted section of the guidewire were disjointed and kinked.The coiled wire was observed to be severely unraveled just proximal to the knot, but not broken.The weld tip was observed to be present and intact and the coiled wire distal to the knot was observed to not be unraveled.The break site of the core wire was observed to be tapered and flat with a granular surface texture, which indicates tensile failure caused by excessive pulling force.The knot in the distal end of the returned guidewire was likely caused by repeated advancement and retraction of the guidewire against resistance within the vessel.H3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported that during a procedure the guide wire came off and unravelled.No patient injury was reported.

• 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: 11361742
• Report Number: 3006260740-2021-00424
• Device Sequence Number: 14323629
• 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,Followup
• Report Date (Section B): 04/22/2021

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2021
• Initial Date Received by Manufacturer: 01/26/2021
• Supplement Date Received by Manufacturer: 04/21/2021
• Initial Report FDA Received Date: 02/22/2021
• Supplement Report FDA Received Date: 05/21/2021
• 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