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

Model Number	3395335Q
Medical Device Problem Codes	Material Frayed (1262); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2021
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 reey1810 showed no similar product complaint(s) from this lot number.
Event or Problem Description
It was reported apparently during the case they fed the guide wire in through the introducer.Upon trying to remove guide wire the radiologist was not able to pull it back through the introducer and had to remove the introducer to pull guide wire out.Once removed there was still a small thread attached and he was able to remove the last bit of the guide wire.The introducer is still attached to the guidewire as they were not able to remove the guidewire.
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, applicable manufacture records, 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 and one 21 g introducer needle were returned for evaluation.An initial visual observation showed use residue on the returned samples.The shaft of the introducer needle was observed to be slightly curved.The guidewire was returned in two segments with the distal segment tied in a knot.The majority of the coiled wire of the proximal guidewire segment was observed to be unraveled.A microscopic observation revealed the bevel of the introducer needle was damaged.The break site in the coiled wire of the guidewire was observed to be angled and granular, and the break site in the core wire of the guidewire was observed to be tapered and somewhat uneven but granular, which suggests 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.This knot, once formed, would prevent passage of the guidewire through the needle and, ultimately, contribute to the breaks in the guidewire in combination with additional withdrawal force.H3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported apparently during the case they fed the guide wire in through the introducer.Upon trying to remove guide wire the radiologist was not able to pull it back through the introducer and had to remove the introducer to pull guide wire out.Once removed there was still a small thread attached and he was able to remove the last bit of the guide wire.The introducer is still attached to the guidewire as they were not able to remove the guidewire.

• Brand Name: POWERPICC SOLO HF 5F RADIOLOGY BASIC TL 135CM
• 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: 12253642
• Report Number: 3006260740-2021-03038
• Device Sequence Number: 11885957
• Product Code: LJS
• UDI-Device Identifier: 00801741028373
• UDI-Public: (01)00801741028373
• 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): 09/27/2021

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: 3395335Q
• Device Catalogue Number: 3395335Q
• Device Lot Number: REEY1810
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2021
• Initial Date Received by Manufacturer: 07/05/2021
• Supplement Date Received by Manufacturer: 09/27/2021
• Initial Report FDA Received Date: 07/30/2021
• Supplement Report FDA Received Date: 09/29/2021
• 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