MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 3MM X 10CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035423100
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The electronic device history record (edhr) review confirms that the device met all material, assembly and performance specifications.During visual inspection, the main coil was detached and no defects were noted to the main coil.Functional testing could not be performed due to the condition of the returned device.In case of this complaint, the reported event was confirmed.Based on the information provided no anomalies were noted to the device prior to use and there is no indication of a user error.As per the event description the coil was successfully detached without difficulty.No defect were noted to the returned main coil.Investigation of the concurrent target coil showed damage to the coil which may have caused the device interaction.An assignable case of caused by other was assigned to the as reported issue 'main coil tangled', the investigation indicates another product/subsequent procedure caused the issue.This is the 2nd of 2nd mdr.
Event or Problem Description
It was reported that during the procedure, the physician was able to implant the first coil without any issue.The physician then implanted the second coil (subject device); however, got tangled with the first coil.Both coils were removed and replaced.No known patient consequences reported.No additional information provided.

• Brand Name: TARGET 360 ULTRA 3MM X 10CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8500304
• Report Number: 3008881809-2019-00093
• Device Sequence Number: 2758785
• Product Code: HCG
• UDI-Device Identifier: 04546540675903
• UDI-Public: 04546540675903
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K153658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 04/10/2019

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: 10/23/2021
• Device Catalogue Number: M0035423100
• Device Lot Number: 20954987
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2019
• Initial Report FDA Received Date: 04/10/2019
• 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: TARGET 360 ULTRA 2MM X 4CM (STRYKER)