MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY STRATA II SHUNT ASSEMBLY, REGULAR, WITH BIOGLIDE; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number	27819
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/17/2017
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 during the procedure, the valve was found to be leaking after being squeezed.According to the report, there was a hole in the middle of the valve.It was stated the physician did not check the valve before surgery.Reportedly, the valve was replaced to complete the procedure and there was no impact to the patient.The patient¿s status was normal.
Additional Manufacturer Narrative
The returned valve was patent.The valve met the requirements for siphon, and reflux testing.However, the device did not meet the r equirements for pressure-flow and preimplantation testing.There was proteinaceous debris observed within the interior and exterior of the valve.Debris within the valve may hold pressure-flow controlling mechanisms open affecting the flow of fluid through the valve.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.¿ the returned valve also did not meet the requirements for leak testing due to a tear observed in the top of the delta chamber.It is unknown how or when this damage occurred.The ifu caution that ¿care should be taken in handling the valves as silicone has a low cut and tear resistance.¿ the ifu also caution that ¿improper use of instruments in the handling or implantation of shunt products may result in the cutting, slitting, or crushing of components.¿ approximately 90 cm of the catheter was returned.The returned catheter did not meet the requirements for patency.There was proteinaceous debris observed within the interior and exterior of the catheter.The instructions for use that accompany the device caution that ¿shunt obstruction may occur in any of the components of the shunt system.The system may become occluded due to blood clots or brain fragments, tumor cell aggregates, bacterial colonization or other debris.¿ a review of the manufacturing records showed no anomalies.All valves are 100% tested at the time of manufacture.All catheters are 100% inspected at the time of manufacture.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: STRATA II SHUNT ASSEMBLY, REGULAR, WITH BIOGLIDE
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 6647925
• Report Number: 2021898-2017-00324
• Device Sequence Number: 16389147
• Product Code: JXG
• UDI-Device Identifier: 00643169010499
• UDI-Public: 00643169010499
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K042465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/10/2017

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: 05/31/2019
• Device Model Number: 27819
• Device Catalogue Number: 27819
• Device Lot Number: E12415
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2017
• Initial Date Received by Manufacturer: 05/18/2017
• Supplement Date Received by Manufacturer: 07/10/2017; 07/10/2017
• Initial Report FDA Received Date: 06/16/2017
• Supplement Report FDA Received Date: 08/07/2017; 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: 53 YR
• Patient Weight: 68