MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES PR HERMETIC VENTRICULAR SMALL CATHETER SET; N/A

Catalog Number	INS4000
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Medsun report# (b)(4) was received with the following information: "while the neurosurgeon was removing the patient's evd catheter, part of the catheter broke off and was retained internally.The broken piece was not visible, and the neurosurgeon sutured the incision site.A ct scan was ordered and confirmed the retained catheter tip size and location.Manufacturer response for hermetic ventricular small catheter set, hermetic ventricular small catheter set (per site reporter) the catheter is the one used on the patient, it is white in color and is not impregnated.The size is 1.3 diameters.However, [(b)(6)] (rep) can¿t say for certain if one is firmer than the other.He stated that there have not been any changes to the polyurethane material catheter, and that there have not been any reports of them breaking.(b)(6)] had some additional questions regarding the drill size use for insertion and the physician¿s technique.Educator informed him that she would forward these questions to the executive medical team.[(b)(6)] can be reached at [(b)(6)].What was the original intended procedure? evd catheter removal".Subsequently we received additional information from customer in response to our questions as follows: please provide the exact implantation date: (b)(6) 2024.Please provide the exact explantation date: (b)(6) 2024.What is the date of the event? (b)(6) 2024.Was the patient under anesthesia when the device broke? yes.Was any medical/surgical intervention performed? if yes, please provide details.Yes, patient returned to or for removal.Please provide patient status/outcome: stable.
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
N/a.
Additional Manufacturer Narrative
The hermetic ventricular small catheter (ins4000) was not returned for evaluation; therefore, an evaluation of the device could not be performed.In addition, no photos were provided to confirm the report; therefore, the reported condition is unconfirmed.Device history record (dhr) review - lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.Failure analysis - the tubing component used in the manufacturing of the reported lot complied with all incoming requirements.The tubing component has been used in used in the manufacturing process of nine (9) additional lots (over 1,000 catheters) and no other complaint has been received for any of these.Additional complaint information states that they ¿can¿t say for certain if one is firmer than the other.¿ it is unknown if they were comparing it to another catheter of the same sku or a different one; however, no changes have been made to the tubing component.Based on the documentation review, there is no indication that this failure is device related.Other reasons for the breakage could be related to catheter entrapment in the patient and/or surgical technique.Root cause - no further evaluation is possible at this time; therefore, the definite root cause cannot be determined.If the product is subsequently returned and/or 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: HERMETIC VENTRICULAR SMALL CATHETER SET
• Common Device Name: N/A
• Manufacturer (Section D): INTEGRA NEUROSCIENCES PR; road 402 north, km 1.2; road 402 north, km 1.2; anasco PR 00610
• Manufacturer (Section G): INTEGRA NEUROSCIENCES PR; road 402 north, km 1.2; anasco PR 00610
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 20363495
• Report Number: 2648988-2024-00036
• Device Sequence Number: 3889651
• Product Code: JXG
• UDI-Device Identifier: 10381780071068
• UDI-Public: 10381780071068
• Combination Product (Y/N): N
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2024

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 Catalogue Number: INS4000
• Device Lot Number: 6727069
• 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: 09/12/2024
• Supplement Date Received by Manufacturer: 11/08/2024
• Initial Report FDA Received Date: 10/03/2024
• Supplement Report FDA Received Date: 12/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/15/2023
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 31 MO
• Patient Sex: Female