MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY STRATA NSC LP SHUNT KIT, CLOSED TIP LUMBAR CATHETER; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Catalog Number	44420
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned valve was patent.The valve met the requirements for reflux, siphon, pressure-flow, pre-implantation, and leak testing.There was proteinaceous debris noted in the interior and exterior of the device.The instructions for use (ifu) that accompany the device caution that ¿shunt obstruction may occur in any of the components of the shunt system.The system may become occluded internally due to tissue fragments, blood clots, tumor cell aggregates, bacterial colonization, or other debris.¿ approximately 65 cm of the peritoneal catheter was returned.The catheter was returned in three separate pieces, measuring 8 cm, 42 cm, and 15 cm, respectively.The returned pieces of the catheter were patent.However, it did not meet the requirements for leak testing due to a tear observed approximately 8 cm and 50 cm from the distal end.It is unknown how or when this damage occurred.The instructions for use that accompany the device cautions that low tear strength is a characteristic of most unreinforced silicone elastomer materials, and that care must be taken with the handling and placement of the silicone elastomer catheter tubing to avoid cuts, nicks, or tears.Approximately 52 cm of the lumbar catheter was returned.The returned catheter was patent and met the requirements for leak testing.There was proteinaceous debris observed on the exterior of the catheter.A review of the manufacturing records showed no anomalies.All catheters are 100% inspected at the time of the manufacture.All valves are 100% tested at the time of manufacture.
Event or Problem Description
It was reported to medtronic neurosurgery that the device¿s reservoir flexibility was poor intra-operatively.According to the report, the device was not used and there was no injury to the patient.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: STRATA NSC LP SHUNT KIT, CLOSED TIP LUMBAR CATHETER
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 6415645
• Report Number: 2021898-2017-00119
• Device Sequence Number: 10947059
• Product Code: JXG
• UDI-Device Identifier: 00643169010796
• UDI-Public: 00643169010796
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K123524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2017

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: 02/28/2021
• Device Catalogue Number: 44420
• Device Lot Number: E10309
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2017
• Initial Date Received by Manufacturer: 02/15/2017
• Supplement Date Received by Manufacturer: 02/15/2017
• Initial Report FDA Received Date: 03/17/2017
• Supplement Report FDA Received Date: 10/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 55