MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET HELICAL NANO 2 MM X 4 CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035452040
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/09/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during repositioning of a coil for embolization of an aneurysm of the posterior communicating artery, the coil stretched and broke in the patient.The broken part of the coil was removed using a snare retrieval device without patient complication due to this event.
Additional Manufacturer Narrative
Analysis of the returned device revealed kinking, stretching, and break at the detachment zone of the main coil, damage of the main coil suture, and kinking of the delivery wire.The kinking of the delivery wire was likely due to handling damage.While review of the manufacturing records did not reveal that the device failed to meet specifications upon release, the damage to the main coil suture is indicative of a manufacturing defect which likely contributed to the reported event and the damages observed during analysis.Therefore, an assignable cause of manufacturing deficiency has been assigned to this investigation.
Event or Problem Description
It was reported that during repositioning of a coil for embolization of an aneurysm of the posterior communicating artery, the coil stretched and broke in the patient.The broken part of the coil was removed using a snare retrieval device without patient complication due to this event.
Additional Manufacturer Narrative
Correction/removal rpt number: the reference number previously provided was incorrect.
Event or Problem Description
It was reported that during repositioning of a coil for embolization of an aneurysm of the posterior communicating artery, the coil stretched and broke in the patient.The broken part of the coil was removed using a snare retrieval device without patient complication due to this event.

• Brand Name: TARGET HELICAL NANO 2 MM X 4 CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 5638016
• Report Number: 3008853977-2016-00171
• Device Sequence Number: 879501
• Product Code: HCG
• UDI-Device Identifier: 07613252600374
• UDI-Public: (01)07613252600374(17)190322(10)18760131
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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
• Remedial Action: Recall,Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2018
• Device Catalogue Number: M0035452040
• Device Lot Number: 18760131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/11/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 05/06/2016
• Supplement Report FDA Received Date: 08/08/2016; 12/12/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 06/06/16-001-R
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention