MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY LUMBAR CATHETER KIT, OPEN TIP, 84 CM; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Catalog Number	44406
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	Therapeutic Response, Decreased (2271)
Date of Event	01/04/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product testing is in progress.A review of the manufacturing records showed no anomalies.All catheters are 100% inspected at the time of manufacture.
Event or Problem Description
It was reported to medtronic neurosurgery that the device leaked cerebrospinal fluid.According to the report, there was patient impact due to this, but the nature of the impact was unobtainable.Reportedly, the device was explanted and a perforation was found on the device.It was stated the patient was under follow-up.
Additional Manufacturer Narrative
Approximately 37 cm of the catheter was returned.Proteinaceous debris was observed on the exterior of the catheter.The catheter was patent however it did not meet requirements for leak testing due to a tear approximately 2.5 cm from the distal end of the catheter.The puncture is consistent with a bevel needle puncture.The distal end appears to be cut to length and the edge appears to be jagged.It is unknown how or when the damage occurred.As part of the manufacturing process alcohol is pumped through the catheter, and any leaks would be detected.No needles are used in the manufacturing processing of the catheter.The instructions for use (ifu) that accompany the device caution that ¿low tear strength is a characteristic of most unreinforced silicone elastomer materials.Care must be taken with the handling and placement of the silicone elastomer catheter tubing to avoid cuts, nicks or tears.¿ a review of the manufacturing records showed no anomalies.All catheters are 100% inspected at the time of manufacture.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: LUMBAR CATHETER KIT, OPEN TIP, 84 CM
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 6299013
• Report Number: 2021898-2017-00036
• Device Sequence Number: 19038143
• Product Code: JXG
• UDI-Device Identifier: 00613994653352
• UDI-Public: 00613994653352
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K091312
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/04/2017

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 Expiration Date: 04/30/2021
• Device Catalogue Number: 44406
• Device Lot Number: E13110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2017
• Initial Date Received by Manufacturer: 01/04/2017
• Supplement Date Received by Manufacturer: Not provided; 02/22/2017
• Initial Report FDA Received Date: 02/02/2017
• Supplement Report FDA Received Date: 03/22/2017; 09/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention