MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET HELICAL NANO 1MM X 3CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035431030
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Subject device is not available.
Event or Problem Description
It was reported that during coil embolization procedure, the 3rd coil (subject device) was difficult to advance into the microcatheter and stretch was confirmed.The subject coil was reliably retrieved with a snare device and the procedure was finished.There were no clinical consequences to the patient.
Additional Manufacturer Narrative
The device history record confirms that the device met all material, assembly and performance specifications.The subject device was not returned for analysis; therefore, physical as well as a functional testing could not be performed.The reported issue is covered in the device directions for use.The risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.Because review and analysis of available information failed to identify a definitive cause, a cause of undeterminable was assigned.
Event or Problem Description
It was reported that during coil embolization procedure, the 3rd coil (subject device) was difficult to advance into the microcatheter and stretch was confirmed.The subject coil was reliably retrieved with a snare device and the procedure was finished.There were no clinical consequences to the patient.

• Brand Name: TARGET HELICAL NANO 1MM 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: 8923564
• Report Number: 3008881809-2019-00247
• Device Sequence Number: 16748560
• Product Code: HCG
• UDI-Device Identifier: 04546540698018
• UDI-Public: 04546540698018
• Combination Product (Y/N): N
• PMA/510(K) Number: K153658
• 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): 10/21/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/09/2022
• Device Catalogue Number: M0035431030
• Device Lot Number: 21211870
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/09/2019
• Supplement Date Received by Manufacturer: 10/03/2019
• Initial Report FDA Received Date: 08/22/2019
• Supplement Report FDA Received Date: 10/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EXCELSIOR SL-10 MICROCATHETER (STRYKER)
• Outcome Attributed to Adverse Event: Required Intervention