MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES PR TRAUMACATH, 35CM; N/A

Model Number	INS8420
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Cerebrospinal Fluid Leakage (1772); Headache (1880)
Date of Event	12/28/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Medwatch report (mw5109804) was received on (b)(6) 2022 with the following information: "caller called to report that she has had seven (7) revisions with her shunt valve.She had experienced internal lacerations, frozen shoulder, adhesions, abdominal wounds that would never heal, csf leakage, headaches and increased pulse rate.She could feel sharp edges from the device in her abdomen.With each revision the surgeon would note that the device is defective, the pop off would not function correctly.When she should have 25 ml of pressure relief, she would get 3ml.Reporter states that she on bedrest for a year and was so depressed prior to her last surgery that she asked the doctor to let die on the table.She no longer feels suicidal due to complete removal of the system and states that her life has improved, but she will never be the same." integra received additional/clarifying information from the patient via telephone conversation on 5/15/2022 as follows: the integra product in question is traumacath, 35cm (ins8420) which was used concomitantly with the medtronic shunt.Patient advised that the integra catheter was not the fault of her injuries/revision procedures and alleged that the shunt was the fault as it would lacerate and stab her which led to the revision procedures.
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 traumacath, 35cm (ins8420) was not returned for evaluation; therefore, an evaluation for root cause of the device could not be performed.Lot number information has been provided; therefore, manufacturing records were reviewed and found no anomalies.However, as per additional information received from the customer (patient) traumacath ins8420/ lot 5264875 was used concomitantly with the medtronic shunt.The client specified that the reported condition was not related to the use of integra¿s traumacath ins8420; instead, the reported condition was related to the use of the medtronic shunt which would ¿lacerate her and was stabbing her¿ leading to revision procedures.The complaint also mentions that ¿the surgeon would note that the device is defective, the pop off would not function correctly¿: the traumacath ins8420 has no parts that ¿pop-off¿; therefore, it is concluded that the catheter is not related to the reported condition.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: TRAUMACATH, 35CM
• 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
• Manufacturer (Section G): INTEGRA NEUROSCIENCES PR; road 402 north, km 1.2; anasco PR
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 14715554
• Report Number: 2648988-2022-00010
• Device Sequence Number: 2201627
• Product Code: JXG
• UDI-Device Identifier: 10381780023890
• UDI-Public: 10381780023890
• Combination Product (Y/N): N
• PMA/510(K) Number: K972994
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2026
• Device Model Number: INS8420
• Device Catalogue Number: INS8420
• Device Lot Number: 5264875
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/25/2022
• Supplement Date Received by Manufacturer: 06/21/2022
• Initial Report FDA Received Date: 06/16/2022
• Supplement Report FDA Received Date: 06/29/2022
• Date Device Manufactured: 02/04/2021
• 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: MEDTRONIC VALVE SHUNT STRATA LUMBAR PERITONEAL
• Patient Age: 50 YR
• Patient Sex: Female