MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD DISPOSABLE CATH PASSER 65CM; SHUNT,NERVOUS SYSTEM & COMPS

Catalog Number	821517
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported that the tip at the end of a disposable catheter passer id(b)(6) broke off during surgery and had to be removed from the patient.There was no surgical delay and no patient harm.No additional surgery was required.
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h6, h11.The disposable catheter passer (id 821517) was not returned for evaluation as the product was discarded and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and device history record (dhr) could not be reviewed.The root cause(s) of the reported issue could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.Additional information: "the passer broke while the surgeon was tunneling.It was in the subcutaneous tissue, identified by x-ray or ct scan (can't remember) and removed at the patient bedside the next day.There was no patient harm other than having to have it removed.".
Event or Problem Description
N/a.

• Brand Name: DISPOSABLE CATH PASSER 65CM
• Common Device Name: SHUNT,NERVOUS SYSTEM & COMPS
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA 02048
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA 02048
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 22054099
• Report Number: 3014334038-2025-00064
• Device Sequence Number: 7985553
• Product Code: JXG
• UDI-Device Identifier: 10381780515500
• UDI-Public: 10381780515500
• Combination Product (Y/N): N
• PMA/510(K) Number: K944222
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2025

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 Catalogue Number: 821517
• Device Lot Number: 7480890
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2025
• Supplement Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 05/20/2025
• Supplement Report FDA Received Date: 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 29 YR
• Patient Sex: Female
• Patient Ethnicity: Hispanic