MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET HELICAL ULTRA 2 MM X 2 CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035432020
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/11/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device is not available.
Event or Problem Description
It was reported that the coil detached prematurely while in the microcatheter.The coil and microcatheter were removed together without clinical consequences to the patient.No further information is available.
Additional Manufacturer Narrative
Product available - corrected to reflect receipt fo the device.The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.The device was returned along with the microcatheter used.Analysis of the device revealed that the proximal contact and delivery wire were kinked likely due to handling.The main coil was returned protruding from the catheter hub.The main coil appeared to have prematurely detached/separated due to a physical break at the detachment zone.In addition the main coil was kinked/bent, stretched and the main coil suture was damaged.A functional evaluation could not be performed due to the condition of the device.A 0.0158" patency mandrel was inserted into the lumen of the returned microcatheter and there were no issues noted.Information available indicated that the device was confirmed to be in good condition after unpacking and preparation.Based on the information available and analysis of the device it is probable that procedural factors limited the performance of the coil resulting the reported event and damages observed.An assignable cause of operational context was assigned to this investigation.
Event or Problem Description
It was reported that the coil detached prematurely while in the microcatheter.The coil and microcatheter were removed together without clinical consequences to the patient.No further information is available.

• Brand Name: TARGET HELICAL ULTRA 2 MM X 2 CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 5906876
• Report Number: 3008881809-2016-00151
• Device Sequence Number: 403092
• Product Code: HCG
• UDI-Device Identifier: 04546540675989
• UDI-Public: (01)04546540675989(17)181031(10)18686186
• Combination Product (Y/N): N
• PMA/510(K) Number: K102672
• 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): 08/11/2016

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: 10/31/2018
• Device Catalogue Number: M0035432020
• Device Lot Number: 18686186
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/11/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/26/2016
• Supplement Report FDA Received Date: 12/07/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1