MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY STRATA II VALVE, SMALL; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Catalog Number	42856
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was unavailable for return.Therefore an evaluation of the device performance was not possible.A review of the manufacturing records showed no anomalies.All valves are 100% tested at the time of manufacture.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported to medtronic neurosurgery that a hole was discovered in the device.According to the report, the doctor opened a 2nd device with a different lot number and completed the case.It was stated that the doctor checked the device before the procedure started so delay was negligible as they pulled another valve from the shelf in the next room.Reportedly, there was no other impact, and the device had no contact with the patient.
Additional Manufacturer Narrative
The returned valve was patent.The valve met the requirements for siphon, pressure-flow, and pre-implantation testing.However, the valve did not meet the requirements for reflux and leak testing due to a tear in the top of the delta chamber.It is unknown how or when this damage occurred.The instructions for use (ifu) that accompany the device caution that ¿improper use of instruments in the handling or implantation of shunt products may result in the cutting, slitting, crushing or breaking of components.¿ the ifu also caution that ¿care should be taken in handling the valves as silicone has a low cut and tear resistance.¿ a review of the manufacturing records showed no anomalies.All valves are 100% tested at the time of manufacture.If information is provided in the future, a supplemental report will be issued.

• Brand Name: STRATA II VALVE, SMALL
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 6785359
• Report Number: 2021898-2017-00436
• Device Sequence Number: 1853545
• Product Code: JXG
• UDI-Device Identifier: 00613994804631
• UDI-Public: 00613994804631
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K042465
• 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): 09/15/2017

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: 11/30/2019
• Device Catalogue Number: 42856
• Device Lot Number: E26112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2017
• Supplement Date Received by Manufacturer: 08/30/2017
• Initial Report FDA Received Date: 08/10/2017
• Supplement Report FDA Received Date: 09/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1