MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 2MM X 4CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035422040
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
Device not returned.
Event or Problem Description
It was reported that during the procedure, the physician was able to implant the first coil (subject device) without any issue.The physician tried implant a second coil; however, got tangled with the first subject coil.The equipment was removed from the patient and replaced.No known patient consequences reported.No additional information provided.
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.The introducer sheath was not returned with the coil.Visual inspection of the device revealed that the coil delivery wire was kinked, likely due to handling.The main coil was found to be kinked and stretched as well.Functional testing could not be performed due to the damaged condition of the returned coil.Based on the information currently available, it is probable that some procedural factors encountered during the procedure limited the performance of the coil contributing to the reported and observed damages.Therefore, an assignable cause of component failure has been assigned to this investigation.B5: executive summary: updated.D10: product available to stryker: updated.D11: concomitant products grid : updated.H3: device evaluated by mfg: updated.This is the 1st of 2 mdr.
Event or Problem Description
It was reported that during the procedure, the physician was able to implant the first coil (subject device) without any issue.The physician then implanted the second coil; however, got tangled with the first subject coil.Both coils were removed and replaced.No known patient consequences reported.No additional information provided.

• Brand Name: TARGET 360 ULTRA 2MM X 4CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8334001
• Report Number: 3008881809-2019-00044
• Device Sequence Number: 59070
• Product Code: HCG
• UDI-Device Identifier: 04546540675842
• UDI-Public: 04546540675842
• 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: Physician
• Type of Report: Initial,Followup
• 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: M0035422040
• Device Lot Number: 20954987
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2019
• Initial Date Received by Manufacturer: 01/17/2019
• Supplement Date Received by Manufacturer: 03/14/2019
• Initial Report FDA Received Date: 02/12/2019
• Supplement 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 3MM X 10CM (STRYKER).; TARGET COIL (STRYKER)N.