MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SOLO2 CATHETER WITH BASIC TRAY (4F) (SINGLE-LUMEN); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint of a damaged stylet is confirmed and was determined to be use related.The product returned for evaluation was a hydrophilic stiffening stylet with a t-lock assembly.Complete breaks were observed in both the core and coil wires.The coil wire was observed to be severely elongated.The distal wire fragment including the weld tip was broken off and not returned.Microscopic inspection of the break in the core wire revealed a granular fracture surface and a tapered break profile.A region of increased luster was observed on the fracture surface of the core wire.Inspection of the break in the coil wire revealed a sharply defined fracture surface.One region of the coil wire fracture surface exhibited a glossy, striated fracture surface.The coil wire was not elongated in the vicinity of the fracture surface.These features were consistent with sharp instrument damage which likely occurred during trimming of the catheter.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported by the customer, powerpicc solo catheter, guidewire drawing.No other information was provided.(b)(6) 2024: during evaluation of the returned stylet, the core wire was found to be severely elongated and broken.

• Brand Name: POWERPICC SOLO2 CATHETER WITH BASIC TRAY (4F) (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: kayla bevins ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 20481347
• Report Number: 3006260740-2024-05983
• Device Sequence Number: 8360230
• Product Code: LJS
• UDI-Device Identifier: 00801741031625
• UDI-Public: (01)00801741031625(10)REHX0251
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/14/2024

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 Model Number: N/A
• Device Catalogue Number: 8194118
• Device Lot Number: REHX0251
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2024
• Initial Report FDA Received Date: 10/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2023
• 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