MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK GDC-10 3D 10MM X 30CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number M00334510340

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/07/2014

Event Type  malfunction  

Event Description

Analysis of the returned device revealed the coil (subject device) had broken near the detachment zone.There were no reported clinical consequences to the patient.

Manufacturer Narrative

The device history record review confirms that the device met all material, assembly and performance specifications.The subject device was returned in an introducer sheath.Visual and optical inspection of the returned device found the coil delivery wire was kinked and damaged.The introducer sheath was kinked.These were believed to be related to handling damage during use.Visual and optical inspection also found the main coil to be stretched and broken.Based on the information, the broken main coil is associated with a product which met all required specifications, but device performance was limited due to procedural factors/operational context.

• Brand Name: GDC-10 3D 10MM 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: alyson harris ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 4331134
• MDR Text Key: 5257381
• Report Number: 3008853977-2014-00396
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/07/2014

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: 01/01/2017
• Device Catalogue Number: M00334510340
• Device Lot Number: 17470699
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2014
• Initial Date FDA Received: 12/15/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/14/2014
• 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