MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK GDC-18 360 14MM X 30CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number M00334814300

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/04/2019

Event Type  malfunction  

Manufacturer Narrative

The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.During the analysis of the returned device, it was revealed that the main coil was stretched and broken.Functional testing could not be performed due to the condition of the device.The reported issue is covered in the device directions for use.The risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.It is most likely that the coil stretched and then broke during manipulation of the coil against friction.Therefore, a cause of procedural factors will be assigned to the investigation.

Event Description

Analysis of the returned device found that the main coil had broken inside the patient.There was no clinical consequence to the patient as a result of this event.

• Brand Name: GDC-18 360 14MM X 30CM
• 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: 9101447
• MDR Text Key: 159615456
• Report Number: 3008881809-2019-00288
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 04546540689917
• UDI-Public: 04546540689917
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 09/21/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Catalogue Number: M00334814300
• Device Lot Number: 19438818
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/17/2019
• Initial Date FDA Received: 09/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2016
• 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: 25 YR