MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD DISPOSABLE CATH PASSER 36CM; SHUNT,NERVOUS SYSTEM & COMPS

Catalog Number	821515
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	05/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A physician reported that during the implantation procedure, while tunneling with a disposable catheter passer (id 821515), a vessel was inadvertently nicked and the patient experienced bleeding.The surgeon made another incision to locate the source, applied direct pressure, and cautery was used to achieve hemostasis.This resolved the issue.According to information provided, it is unknown if there is any issue with the catheter passer.It is unknown if there was a surgical delay due to device issue, or if the patient experienced any signs and symptoms due to blood loss.
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 821515) was not returned for evaluation after three good faith attempts (gfes) were made.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, however, a potential root cause is: user uses an incompatible/ inappropriate technique or tool.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.
Event or Problem Description
N/a.

• Brand Name: DISPOSABLE CATH PASSER 36CM
• 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: 22283718
• Report Number: 3014334038-2025-00082
• Device Sequence Number: 8310028
• Product Code: JXG
• UDI-Device Identifier: 10381780515487
• UDI-Public: 10381780515487
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 821515
• 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: 06/02/2025
• Supplement Date Received by Manufacturer: 10/02/2025
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 10/24/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: INSPIRE STIMULATION LEAD MODEL# 4063SI.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown