MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET HELICAL NANO 1MM X 2CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035431020
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is 2 of 2 reports.The device is not available to the manufacturer.
Event or Problem Description
It was reported that during a coil embolization procedure, the coil (subject device) experienced resistance during insertion into microcatheter and upon removal, the coil delivery wire broke.The coil was retrieved along with the microcatheter.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.Visual inspection of the device revealed that the delivery wire was kinked, likely due to handling.The main coil was found to be kinked and appears to be physically detached at the main coil junction.During functional testing, coil could not be advanced through the introducer sheath as the main coil was stuck in the tip of the introducer sheath.The physician may have perceived the observed damages (coil delivery wire kink) as break and reported it as such; however, no break was identified on the device.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.
Event or Problem Description
It was reported that during a coil embolization procedure, the coil (subject device) experienced resistance during insertion into microcatheter and upon removal, the coil delivery wire broke.The coil was retrieved along with the microcatheter.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.Visual inspection of the device revealed that the delivery wire was kinked, likely due to handling.The main coil was found to be kinked and appears to be physically detached at the main coil junction.During functional testing, coil could not be advanced through the introducer sheath as the main coil was stuck in the tip of the introducer sheath.The physician may have perceived the observed damages (coil delivery wire kink) as break and reported it as such; however, no break was identified on the device.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.
Event or Problem Description
It was reported that during a coil embolization procedure, the coil (subject device) experienced resistance during insertion into microcatheter and upon removal, the coil delivery wire broke.The coil was retrieved along with the microcatheter.There were no reported clinical consequences to the patient.

• Brand Name: TARGET HELICAL NANO 1MM X 2CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 7838732
• Report Number: 3008881809-2018-00377
• Device Sequence Number: 11346906
• Product Code: HCG
• UDI-Device Identifier: 04546540698001
• UDI-Public: 04546540698001
• 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
• Report Date (Section B): 10/18/2018

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: 03/12/2021
• Device Catalogue Number: M0035431020
• Device Lot Number: 20388291
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2018
• Initial Date Received by Manufacturer: 08/21/2018
• Supplement Date Received by Manufacturer: 10/05/2018
• Initial Report FDA Received Date: 08/31/2018
• Supplement Report FDA Received Date: 10/18/2018
• 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 MICROCATHETER(STRYKER)
• Patient Age: 56 YR
• Patient Weight: 58