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

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that product has a defect (bended guidewire) so can't be used with patient and need to open new package.
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 manufacturer has received the sample and is pending evaluation.Results are expected soon.
Event or Problem Description
It was reported that product has a defect (bended guidewire) so can't be used with patient and need to open new package.No other information was provided.
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.Based on a review of applicable information, the following was concluded: the complaint of kinked guidewire is confirmed; however, the root cause could not be determined.Three photographs of a nitinol guidewire were returned for evaluation.An initial visual observation of the photographs showed a kink in the guidewire near the distal end of the guidewire.What appears to be use residue was observed on the sample in one of the returned photographs.The other photographs showed the guidewire in a plastic bag.The weld tip appears to be present and intact.No further details of the damage were observed in the returned photographs.This complaint will be recorded for future trending and monitoring purposes.
Additional Manufacturer Narrative
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 complaint of a bent guidewire is confirmed and was determined to be use related.The product returned for evaluation was an ir guidewire in its plastic hoop.The tip of the blue end cap on the plastic hoop was broken off.The guidewire was observed to be bent near the distal end.Light use residue was observed on the guidewire.Microscopic inspection of distal end of the guidewire confirmed a bend in the guidewire.The guidewire core wire and coil wire were intact.The bend in the guidewire likely occurred during insertion or retraction of the guidewire against resistance.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported that product has a defect (bended guidewire) so can't be used with patient and need to open new package.No other information was provided.

• Brand Name: POWERPICC 5F DL POLYURETHANE CATHETER RADIOLOGY (135 CM NITINOL GUIDE)
• 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
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 17586248
• Report Number: 3006260740-2023-03593
• Device Sequence Number: 11991350
• Product Code: LJS
• UDI-Device Identifier: 00801741027949
• UDI-Public: (01)00801741027949
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K051672
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/15/2024

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 Expiration Date: 02/28/2026
• Device Model Number: N/A
• Device Catalogue Number: 3275335
• Device Lot Number: REHQ1838
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2023
• Supplement Date Received by Manufacturer: 12/15/2023; 04/15/2024
• Initial Report FDA Received Date: 08/21/2023
• Supplement Report FDA Received Date: 12/23/2023; 04/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown