MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY STRATA NSC SNAP SHUNT ASSEMBLY, REGULAR; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Catalog Number	27740
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Only the snap base was returned.The base was patent and passed leak testing.Proteinaceous debris was observed on the exterior of the base.One of the end appears to be jagged.It is unknown how or when the damage occurred.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 physician was implanting a device, and they had already passed the peritoneal cat heter.According to the report, the physician was getting ready to snap the snap base onto the ventricular catheter when they realized the plastic on the snap base was bent preventing it from snapping into place.Reportedly, the physician ended up cutting off the snap base, opening a new snap shunt, and cutting off the snap base and using a straight connector to connect it to the rest of the original assembly that was already implanted.It was stated there was no patient injury, and the patient was well.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: STRATA NSC SNAP SHUNT ASSEMBLY, REGULAR
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 6609611
• Report Number: 2021898-2017-00298
• Device Sequence Number: 11055355
• Product Code: JXG
• UDI-Device Identifier: 00643169496866
• UDI-Public: 00643169496866
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K033850
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2017

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: 03/31/2021
• Device Catalogue Number: 27740
• Device Lot Number: E11561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2017
• Initial Date Received by Manufacturer: 05/03/2017
• Supplement Date Received by Manufacturer: 05/03/2017
• Initial Report FDA Received Date: 06/02/2017
• Supplement Report FDA Received Date: 10/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR