MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK GDC-10 360 SOFT 3MM X 6CM SR; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number M003347306SR0

Device Problem Premature Activation (1484)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/05/2017

Event Type  malfunction  

Manufacturer Narrative

The device history record review confirms that the device met all material, assembly and performance specifications.Visual inspection of the device revealed that the main coil had prematurely detached from the coil delivery wire.The main coil was noted to be kinked and stretched as well.Functional testing could not be performed due to the damaged condition of the returned coil.Based on the information currently available,it is likely that the main coil was damaged during use thus limiting the performance of the coil during the clinical procedure.Therefore, an assignable cause of operational context has been assigned to this investigation.

Event Description

Analysis of the returned device noted that the main coil had prematurely detached from the coil delivery wire.No consequences to the patient were reported.

• Brand Name: GDC-10 360 SOFT 3MM X 6CM 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: 7383949
• MDR Text Key: 103925030
• Report Number: 3008881809-2018-00141
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 04546540689801
• UDI-Public: (01)04546540689801(17)180930(10)18613621
• 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: 03/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Model Number: M003347306SR0
• Device Catalogue Number: M003347306SR0
• Device Lot Number: 18613621
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2015
• 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: 61 YR