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

Catalog Number	M0035431030
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is the second of 2 reports.The device is not available to the manufacturer.
Event or Problem Description
It was reported that the coil (subject device) could not be delivered out of the microcatheter, the physician experienced difficulty and during withdrawal, the coil broke.There were no reported clinical consequences to the patient.
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.The subject device was returned within the introducer sheath and dispenser hoop.Visual inspection of the device revealed that the main coil was severely kinked.During functional testing, the coil could not be advanced through the introducer sheath, only retracted.The physician may have perceived the main coil kink as the main coil break due to the reported friction during advancement of the coil inside the microcatheter.It is probable that the device was damaged during the clinical procedure due to some procedural/anatomical factors encountered causing the as reported event, therefore assignable cause of procedural factors will be assigned to reported and observed issues.
Event or Problem Description
It was reported that the coil (subject device) could not be delivered out of the microcatheter, the physician experienced difficulty and during withdrawal, the coil broke.There were no reported clinical consequences to the patient.
Event or Problem Description
It was reported that the coil (subject device) could not be delivered out of the microcatheter, the physician experienced difficulty and during withdrawal, the coil broke.There were no reported clinical consequences to the patient.
Additional Manufacturer Narrative
The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.

• 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: 8858052
• Report Number: 3008881809-2019-00227
• Device Sequence Number: 2397059
• Product Code: HCG
• UDI-Device Identifier: 04546540698018
• UDI-Public: 04546540698018
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• 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,Followup
• Report Date (Section B): 09/27/2019

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: 09/24/2021
• Device Catalogue Number: M0035431030
• Device Lot Number: 20891118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2019
• Initial Date Received by Manufacturer: 07/25/2019
• Supplement Date Received by Manufacturer: 09/12/2019; 09/12/2019
• Initial Report FDA Received Date: 08/02/2019
• Supplement Report FDA Received Date: 09/24/2019; 09/27/2019
• 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)
• Patient Age: 64 YR
• Patient Weight: 80