MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK GDC-10 3D 7MM X 15CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M00334571540
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/18/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Subject device is not available.
Event or Problem Description
It was reported that during a coil embolization procedure, when the subject coil was retracted into the microcatheter, it broke off into the microcatheter.There was no adverse consequences to the patient.
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.The device was returned with the delivery wire within the introducer sheath and the main coil separate to the delivery wire and sheath.Visual examination of the returned device revealed that the coil introducer sheath was damaged, likely due to handling damage.It was also observed that the main coil was noted to have become broken from the polyethylene terephthalate (pet) joint due to physical force as evidenced by the damage noted to the pet and the severe stretching sustained to the main coil.Information available indicated that the device was confirmed to be in good condition prior to use.According to the additional information, the customer stated that the coil broke within the microcatheter when the user retracted the coil back into the catheter lumen.The condition of the returned device indicates that the coil sustained excessive physical force, became stretched, and subsequently broke from the pet junction.It is likely that procedural factors contributed to the reported and observed damages limiting the performance of the coil during the clinical procedure.Therefore, an assignable cause of operational context has been assigned to the main coil break and the observed main coil stretch.
Event or Problem Description
It was reported that during a coil embolization procedure, when the subject coil was retracted into the microcatheter, it broke off into the microcatheter.There was no adverse consequences to the patient.

• Brand Name: GDC-10 3D 7MM X 15CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 5919734
• Report Number: 3008881809-2016-00156
• Device Sequence Number: 13604336
• Product Code: HCG
• UDI-Device Identifier: 04546540689528
• UDI-Public: (01)04546540689528(17)190131(10)18791249
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K031049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2017

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: 01/31/2018
• Device Catalogue Number: M00334571540
• Device Lot Number: 18791249
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/18/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/31/2016
• Supplement Report FDA Received Date: 04/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR