MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC 5F SINGLE-LUMEN POLYURETHANE CATHETER RADIOLOGY 135 CM GW; 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	05/10/2022
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 redr1787 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that guidewire was found kink during insertion.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.The following were reviewed as part of this investigation: patient severity, complaint and lot history review, applicable previous investigation(s), sample (if available), 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.Guidewire in a plastic hoop was returned for evaluation.An initial visual observation showed no obvious evidence of use on the returned sample.Many bends were observed in distal end of the returned guidewire.No breaks were found within the returned guidewire during tactile evaluation.A microscopic observation revealed a kink in the coiled wire of the guidewire approximately 2.1 cm proximal to the distal tip.The weld tip was observed to be present and intact.While the returned guidewire was found to be bent in multiple locations, it was not possible to determine when or where the sample was damaged.Possible causes include damage during packaging, handling, manipulation, or use.H3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported that guidewire was found kink during insertion.No other information was provided.

• Brand Name: POWERPICC 5F SINGLE-LUMEN POLYURETHANE CATHETER RADIOLOGY 135 CM GW
• 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 14581037
• Report Number: 3006260740-2022-02055
• Device Sequence Number: 5492181
• Product Code: LJS
• UDI-Device Identifier: 00801741027673
• UDI-Public: (01)00801741027673
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K033389
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2022

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: 07/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 3175135
• Device Lot Number: REDR1787
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/10/2022
• Supplement Date Received by Manufacturer: 08/01/2022
• Initial Report FDA Received Date: 06/02/2022
• Supplement Report FDA Received Date: 08/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2019
• 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