MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 6MM X 20CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035476200
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure of the aneurysm embolization case, the operator used coil to frame and microcatheter to support.After introducing the coil from introducing sheath to go into the microcatheter, the operator checked under x-ray for the coil stretched and decided to withdraw the coil.While retracting the coil (subject device) from the hub of microcatheter, it got pre detached.The physician replaced it with a new device, and continued the procedure without clinical consequences to the patient.
Event or Problem Description
It was reported that during the procedure of the aneurysm embolization case, the operator used coil to frame and microcatheter to support.After introducing the coil from introducing sheath to go into the microcatheter, the operator checked under x-ray for the coil stretched and decided to withdraw the coil.While retracting the coil (subject device) from the hub of microcatheter, it got pre detached.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
Additional Manufacturer Narrative
Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.Visual inspection indicated that the main coil was not retuned.The main coil was electrolytically detached.The coil delivery wire was kinked/bent and it was damaged.Functional test: not required.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 damage noted to the device would be indicative of the as reported defect.The as reported/as analyzed main coil prematurely detached/separated inside patient as reported main coil stretched and as analyzed main coil kinked bent will be assigned procedural factors as the defect 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 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.

• Brand Name: TARGET 360 SOFT 6MM 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: 10848350
• Report Number: 3008881809-2020-00347
• Device Sequence Number: 19636121
• Product Code: HCG
• UDI-Device Identifier: 04546540676542
• UDI-Public: 04546540676542
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 12/16/2020

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: 04/08/2023
• Device Model Number: M0035476200
• Device Catalogue Number: M0035476200
• Device Lot Number: 22213502
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2020
• Initial Date Received by Manufacturer: 10/21/2020
• Supplement Date Received by Manufacturer: 11/30/2020
• Initial Report FDA Received Date: 11/16/2020
• Supplement Report FDA Received Date: 12/16/2020
• 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: ECHELON-10 MICRO CATHETER (MEDTRONIC); ECHELON-10 MICRO CATHETER (MEDTRONIC)
• Patient Age: 71 YR
• Patient Weight: 70