MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SOLO CATHETER WITH SHERLOCK 3CG (TPS) STYLET 5F MAXIMAL BARRIER TRAY; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Codes	Break (1069); Material Frayed (1262)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/17/2023
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 manufacturer has received the sample and will evaluate.Results are expected soon.
Event or Problem Description
It was reported by customer that patient booked for interventional radiology procedure to retrieve vascular foreign body.Procedure went as planned.Foreign body removed from pulmonary artery described as "linear foreign body from left lower lobe pulmonary artery".Foreign body appears to be part of a wire, from insertion of picc.No other information was provided.
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 fractured stylet is confirmed; however, the exact cause is unknown.One photograph of a 3cg stylet was returned for evaluation.An initial visual observation of the photograph showed a segment of a 3cg stylet with a rounded epoxy tip on the distal end, a kink midway down the segment, and a fractured proximal end.Use residue cannot be discerned from the returned photograph, and although damage is observed, no details of the damage can be discerned.There were no distinguishing features in the returned photograph of the device which could aid in identification of a specific root cause.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported by customer that patient booked for interventional radiology procedure to retrieve vascular foreign body.Procedure went as planned.Foreign body removed from pulmonary artery described as "linear foreign body from left lower lobe pulmonary artery".Foreign body appears to be part of a wire, from insertion of picc.No other information was provided.

• Brand Name: POWERPICC SOLO CATHETER WITH SHERLOCK 3CG (TPS) STYLET 5F MAXIMAL BARRIER TRAY
• 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: maddy vincent ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 18669837
• Report Number: 3006260740-2024-00419
• Device Sequence Number: 12561416
• Product Code: LJS
• UDI-Device Identifier: 00801741034602
• UDI-Public: (01)00801741034602
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• 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): 04/09/2024

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: 1295108D
• Device Lot Number: REHV1206
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 04/09/2024
• Initial Report FDA Received Date: 02/08/2024
• Supplement Report FDA Received Date: 04/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2023
• 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; Other
• Patient Age: 51 YR
• Patient Sex: Male