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

Catalog Number	M0035475150
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/28/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluated by mfr: not received.
Event or Problem Description
It was reported that during the procedure the coil (subject device) prematurely detached in the catheter while inside the patient.The pre-detached coil segment was removed with successfully with a stent, causing a two hour delay in the procedure.The procedure was completed successfully.There were no known clinical consequences to the patient reported.
Additional Manufacturer Narrative
The device history record confirms that the device met all material, assembly and performance specifications.Visual inspection was performed on the returned sample and it was observed the distal tip was intact but the main coil was severely stretched and was returned detached and broken.In addition, the suture was damaged.Functional testing was not completed because the reported defect was confirmed during analysis.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.The reported event was confirmed.The device was returned for analysis and the main coil was found broken, stretched, had suture damage and prematurely detached.In the case of this complaint, it is most likely that anatomical or procedural factors resulted in the coil damage and eventually detached when trying to remove.This complaint appears to be associated with a product that met stryker and design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural factors during use.Therefore an assignable cause of procedural factors will be assigned to the reported issue.
Event or Problem Description
It was reported that during the procedure the coil (subject device) prematurely detached in the catheter while inside the patient.The pre-detached coil segment was removed with successfully with a stent, causing a two hour delay in the procedure.The procedure was completed successfully.There were no known clinical consequences to the patient reported.

• Brand Name: TARGET 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: 9344647
• Report Number: 3008881809-2019-00351
• Device Sequence Number: 14156163
• Product Code: HCG
• UDI-Device Identifier: 04546540676504
• UDI-Public: 04546540676504
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• 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): 01/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/04/2021
• Device Catalogue Number: M0035475150
• Device Lot Number: 20973675
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2019
• Initial Date Received by Manufacturer: 10/28/2019
• Supplement Date Received by Manufacturer: 12/23/2019
• Initial Report FDA Received Date: 11/19/2019
• Supplement Report FDA Received Date: 01/13/2020
• 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 (STRYKER)
• Outcome Attributed to Adverse Event: Required Intervention