MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET HELICAL NANO 1.5MM X 3CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035431530
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/18/2017
Type of Reportable Event	Malfunction
Additional 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 the coil delivery wire was kinked likely due to handling damage of the device.It was also found that the main coil was protruding from the sheath, stretched and broken, and the main coil suture was damaged (physical break).It is probable that the device was damaged during the clinical procedure causing the as reported event.Therefore, an assignable cause of operational context has been assigned to this investigation.
Event or Problem Description
Based on the result of the investigation of the returned product, it was found that the main coil (subject device) was broken.There was no impact to the patient.

• Brand Name: TARGET HELICAL NANO 1.5MM X 3CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 6793568
• Report Number: 3008881809-2017-00242
• Device Sequence Number: 1116529
• Product Code: HCG
• UDI-Device Identifier: 04546540698049
• UDI-Public: (01)04546540698049(17)190731(10)19204072
• Combination Product (Y/N): N
• PMA/510(K) Number: K113412
• 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
• Report Date (Section B): 08/14/2017

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: 07/31/2019
• Device Model Number: M0035431530
• Device Catalogue Number: M0035431530
• Device Lot Number: 19204072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2017
• Initial Report FDA Received Date: 08/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1