MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 5MM X 15CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036125150
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that when the coil (subject device) was being pulled back for repositioning, the coil broke inside the microcatheter.The broken 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.The subject device is not available; therefore, functional testing as well as physical analysis cannot be performed.Information available indicated that the device was confirmed to be in good condition prior to use.Based on the information currently available, the exact cause for the reported event cannot be determined.
Event or Problem Description
It was reported that when the coil (subject device) was being pulled back for repositioning, the coil broke inside the microcatheter.The broken 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 was performed on the returned sample and it was observed that the main coil was seen to be protruding from the distal end of the catheter.The main coil was removed and noted to extremely stretched and broken at the proximal end.Functional testing could not be performed due to the damaged condition of the returned coil.It is likely that the main coil was damaged during use thus limiting the performance of the coil during the clinical procedure.Therefore, an assignable cause of component failure has been assigned to this investigation.
Event or Problem Description
It was reported that when the coil (subject device) was being pulled back for repositioning, the coil broke inside the microcatheter.The broken coil was retrieved along with the microcatheter.There were no reported clinical consequences to the patient.

• Brand Name: TARGET XL 360 SOFT 5MM X 15CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 7907623
• Report Number: 3008881809-2018-00418
• Device Sequence Number: 16512280
• Product Code: HCG
• UDI-Device Identifier: 07613327128291
• UDI-Public: 07613327128291
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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): 04/18/2019

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: 04/28/2021
• Device Catalogue Number: M0036125150
• Device Lot Number: 20504117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2018
• Initial Date Received by Manufacturer: 09/18/2018
• Supplement Date Received by Manufacturer: 11/15/2018; 04/15/2019
• Initial Report FDA Received Date: 09/25/2018
• Supplement Report FDA Received Date: 11/15/2018; 04/18/2019
• 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: MICROCATHETER (UNKNOWN MANUFACTURER)