MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 6 FR D/L POWERPICC BASIC TRAY W/70 CM GUIDEWIRE; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Codes	Defective Component (2292); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2022
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 regq3926 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that during catheter insertion, the catheter was found difficult to insert.After removal, the wire and catheter were found deformed.Patient status/ intervention: change new wire.
Event or Problem Description
It was reported that during catheter insertion, the catheter was found difficult to insert.After removal, the wire and catheter were found deformed.Patient status/ intervention: change new wire.
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 batch history, applicable previous investigation(s), applicable manufacturing records, photo analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a deformed guidewire was confirmed but the cause is unknown.A photograph of the 0.018¿ stainless steel guidewire with a gold-plated tungsten tip was returned for evaluation.The distal tungsten tip was deformed with the tip bent and coiled upon itself.The observable features on the submitted photographs did not contain enough information to identify a specific root cause of the reported event.A review of the manufacture quality and inspection records for the specific lot involved found no potentially related issues encountered during the manufacture and assembly of that product lot.Possible contributing factors for a bent wire could include insertion/removal against resistance or insertion through a tortuous path.H3 other text: evaluation findings are in section h11.

• Brand Name: 6 FR D/L POWERPICC BASIC TRAY W/70 CM 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
• 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: 15736122
• Report Number: 3006260740-2022-04288
• Device Sequence Number: 14182522
• Product Code: LJS
• UDI-Device Identifier: 00801741028014
• UDI-Public: (01)00801741028014
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K050931
• 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
• Report Date (Section B): 11/21/2022

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: 05/31/2025
• Device Model Number: N/A
• Device Catalogue Number: 3276155
• Device Lot Number: REGQ3926
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/19/2022
• Supplement Date Received by Manufacturer: 11/21/2022
• Initial Report FDA Received Date: 11/04/2022
• Supplement Report FDA Received Date: 11/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2022
• 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