MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 5MM X 20CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035475200
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that during the procedure the subject coil deployed prematurely while it was inside the micro catheter.The subject coil was completely removed from the patient¿s anatomy and replaced with a similar device.The procedure was completed successfully with no clinical consequences reported to the patient due to this event.
Additional Manufacturer Narrative
H4 manufacturing date ¿ added h3 device evaluated by mfg ¿updated h3 summary attached - updated d4 expiration date - added d9/h3 product available to stryker ¿ updated d9 returned to manufacturer on ¿updated due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.The device was returned within the introducer sheath.The lot number was confirmed with the packaging returned with the device.On visual inspection, the proximal contact wire was intact.The coil delivery wire was kinked/bent.The main coil was detached.The distal tip was found to be intact.The main coil was kinked/bent.The main coil was stretched.The suture was damaged.Functional test was not required as the reported defects were 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 damage noted to the device would be indicative of the as reported defect.The as reported/as analyzed main coil prematurely detached/separated during use and main coil kinked/bent and as analyzed main coil stretched & main coil suture damage will be assigned procedural factors as these defects appear 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 or anatomical factors during use.It can be presumed that the delivery wire was damaged during the procedure as force may have been applied when the friction was felt.Because this defect appears to be associated with handling of the product or portion of the product during the procedure/upon removal of the product from the packaging/preparation of the product prior to use, a probable cause of handling damage will be assigned to the as analyzed coil delivery wire kinked/bent¿.
Event or Problem Description
It was reported that during the procedure the subject coil deployed prematurely while it was inside the micro catheter.The subject coil was completely removed from the patient¿s anatomy and replaced with a similar device.The procedure was completed successfully with no clinical consequences reported to the patient due to this event.

• Brand Name: TARGET 360 SOFT 5MM X 20CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• MDR Report Key: 10897248
• Report Number: 3008881809-2020-00360
• Device Sequence Number: 14259901
• Product Code: HCG
• UDI-Device Identifier: 04546540676511
• UDI-Public: 04546540676511
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• 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): 01/07/2021

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: 12/15/2022
• Device Model Number: M0035475200
• Device Catalogue Number: M0035475200
• Device Lot Number: 22017454
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2020
• Initial Date Received by Manufacturer: 11/03/2020
• Supplement Date Received by Manufacturer: 12/17/2020
• Initial Report FDA Received Date: 11/24/2020
• Supplement Report FDA Received Date: 01/07/2021
• 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: SL -10 MICRO CATHETER (STRYKER)