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

Catalog Number	821517
Medical Device Problem Codes	Difficult to Insert (1316); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
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.
Event or Problem Description
A facility reported the when tunneling using a catheter passer (id (b)(6)) it was difficult to introduce peritoneal catheter and difficult to remove the tunneler.No patient injury reported; however, there was a 30 minutes surgical delay due to product problem.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h10 catheter passer was not returned for evaluation; therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.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.

• 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
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 17995304
• Report Number: 3014334038-2023-00174
• Device Sequence Number: 12451235
• 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: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2024

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 Catalogue Number: 821517
• Device Lot Number: 6621010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/11/2023
• Supplement Date Received by Manufacturer: 02/16/2024
• Initial Report FDA Received Date: 10/24/2023
• Supplement Report FDA Received Date: 03/06/2024
• Date Device Manufactured: 09/19/2022
• 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 Sex: Unknown