MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK GDC-10 360 6MM X 15CM SR; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number M003346615SR0

Device Problem Premature Activation (1484)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/06/2018

Event Type  malfunction  

Manufacturer Narrative

The device history record review confirms that the device met all material, assembly and performance specifications.Visual examination of the returned device revealed that dried blood and procedural fluids within the introducer sheath.The introducer sheath was observed to be kinked at 11cm from the distal end likely due to handling damages that limited the performance of the device during procedure.It was also observed that the main coil was physically detached/ separated at the detachment area.The main coil was not returned.During functional testing, the introducer sheath was flushed and traces of blood exited.The delivery wire was advanced through the introducer sheath and resistance was experienced.It is most likely that the friction and observed premature detachment of the main coil were due to some procedural/anatomical factors encountered during use.Therefore, an assignable cause of operational context has been assigned to the friction and observed premature detachment of the main coil.

Event Description

Based on review of the investigation, it was found that the main coil was prematurely detached inside the patient during insertion into the microcatheter.There was no clinical consequences to the patient.

• Brand Name: GDC-10 360 6MM X 15CM SR
• Type of Device: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 7616885
• MDR Text Key: 111637387
• Report Number: 3008881809-2018-00273
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 04546540689672
• UDI-Public: 04546540689672
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: K042539
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: M003346615SR0
• Device Lot Number: 18615129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/24/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 78