MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY STRATA NSC LUMBOPERITONEAL SHUNT KIT; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number	44420
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported the end of the catheter broke during the procedure.The product was not used and there was no injury to the patient.
Additional Manufacturer Narrative
The catheter was returned at length 33.13 inches.The catheter did not meet the requirement for leak test due to 4 tears near the distal end of the catheter.The catheter was distorted near the distal end.It is unknown how or when this damage occurred.The instructions for use cautions, ¿care must be taken to avoid stretching or kinking the catheters at any point along their course or damaging the tubing or slit valves during handling or passing the catheter with a catheter passer.Care must be taken during the procedure to avoid putting cuts, punctures and holes in the catheter.¿ there was proteinaceous debris on the exterior of the catheter.The instructions for use cautions, ¿care must be taken to ensure that particulate contaminants are not introduced into shunt components during preimplantation testing or handling.Introduction of contaminants could result in improper performance of the shunt system.Particulate matter that enters the shunt system may result in shunt occlusion, or may also hold pressure/flow controlling mechanisms open, resulting in over-drainage.¿ if information is provided in the future, a supplemental report will be issued.

• Brand Name: STRATA NSC LUMBOPERITONEAL SHUNT KIT
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 8241873
• Report Number: 2021898-2019-00023
• Device Sequence Number: 13984600
• Product Code: JXG
• UDI-Device Identifier: 00643169975866
• UDI-Public: 00643169975866
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K091312
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2019

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 Expiration Date: 08/31/2023
• Device Model Number: 44420
• Device Catalogue Number: 44420
• Device Lot Number: E53891
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2019
• Supplement Date Received by Manufacturer: 01/29/2019
• Initial Report FDA Received Date: 01/11/2019
• Supplement Report FDA Received Date: 02/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1