MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SOLO CATHETER 4F RADIOLOGY BASIC TRAY (SINGLE-LUMEN); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2024
Type of Reportable Event	Serious Injury
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 complaint of a broken guidewire was confirmed but the cause is unknown.Two photographs of the implicated guidewire were returned for evaluation.The guidewire contained a complete break in the central core wire and the outer coil wire.The coil wire was elongated and unraveled near the break site.The distal manufactured weld tip was intact on the distal segment of the wire.Elongation of the coil wire can occur when the inner core wire is either broken or sheared.The exact root cause of the damage could not be determined from the photograph alone.Microscopic examination and dimensional analysis could not be conducted without the physical sample.Possible contributing factors could include the insertion technique, dimensional incompatibility between interfacing devices, or the guidewire being retracted through the needle.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported by customer that the guide crumbled and disintegrated during installation.This had serious consequences for a patient who required surgery to remove guidewire fragments stuck in his peripheral venous system.Additional information received may 1 2024: a piece of the guide wire broke off at installation when they were trying to retrieve the wire and stayed at the patient¿s insertion site.The intensivist was able to make a small incision at the insertion site and retrieve the small piece from the patient.The piece did not go into the patient¿s blood stream.
Event or Problem Description
It was reported by customer that the guide crumbled and disintegrated during installation.This had serious consequences for a patient who required surgery to remove guidewire fragments stuck in his peripheral venous system.Additional information received may 1 2024: a piece of the guide wire broke off at installation when they were trying to retrieve the wire and stayed at the patient¿s insertion site.The intensivist was able to make a small incision at the insertion site and retrieve the small piece from the patient.The piece did not go into the patient¿s blood stream.
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 manufacturer has received the sample and will evaluate.Results are expected soon.

• Brand Name: POWERPICC SOLO CATHETER 4F RADIOLOGY BASIC TRAY (SINGLE-LUMEN)
• 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: 19321619
• Report Number: 3006260740-2024-02369
• Device Sequence Number: 17732114
• Product Code: LJS
• UDI-Device Identifier: 00801741027765
• UDI-Public: (01)00801741027765
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 3194155
• Device Lot Number: REHU2613
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2024
• Supplement Date Received by Manufacturer: 07/12/2024
• Initial Report FDA Received Date: 05/15/2024
• Supplement Report FDA Received Date: 07/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2023
• 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: Required Intervention
• Patient Sex: Unknown