MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 1MM X 3CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035421030
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during the right mca aneurysm procedure, a guide wire was used to bring the microcatheter to the 1/3 of the aneurysm and framed it with the coil.Physician chose the subject coil to fill the aneurysm, but it was hard to be delivered into the microcatheter.On withdrawal, tip of the subject coil was found broken.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 during the right mca aneurysm procedure, a guide wire was used to bring the microcatheter to the 1/3 of the aneurysm and framed it with the coil.Physician chose the subject coil to fill the aneurysm, but it was hard to be delivered into the microcatheter.On withdrawal, tip of the subject coil was found broken.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.The device was received.The reported lot number was confirmed from the packaging label.During visual inspection, the coil delivery wire was found to be kinked/bent.The main coil was noted to be attached to the delivery wire.The main coil was noted to be kinked/bent.On functional testing, coil introducer sheath friction was detected when advancing coil through introducer sheath.Main coil was advanced through the demo catheter without any resistance.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.During analysis the main coil and coil delivery wire were found to be kinked/bent.In the case of this complaint it is most likely that the coil got damaged during coil advancement against friction.An assignable cause of 'not confirmed' was assigned to the as reported defect ¿main coil broken/fractured during use' as the issue included a returned product review (visual, physical, and/or performance testing) which showed no evidence of either the alleged issue(s) or any defect which could have contributed to the event.This complaint appears to be associated with a product that met stryker 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 as reported, 'main coil difficulty inserting', as well as to the as analyzed 'main coil kinked/bent' and 'coil introducer sheath friction'.The as analyzed 'coil delivery wire kinked/bent' will be assigned handling damage as this complaint appears to be associated with handling of the product or portion of the product during the procedure, a probable cause of handling damage was assigned.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.

• Brand Name: TARGET 360 NANO 1MM X 3CM
• 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: 12288084
• Report Number: 3008881809-2021-00327
• Device Sequence Number: 4672461
• Product Code: HCG
• UDI-Device Identifier: 04546540697974
• UDI-Public: 04546540697974
• 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): 09/05/2021

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: 11/17/2023
• Device Model Number: M0035421030
• Device Catalogue Number: M0035421030
• Device Lot Number: 22590396
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2021
• Initial Date Received by Manufacturer: 07/16/2021
• Supplement Date Received by Manufacturer: 08/23/2021
• Initial Report FDA Received Date: 08/06/2021
• Supplement Report FDA Received Date: 09/05/2021
• 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: ECHELON MICROCATHETER(MEDTRONICS); SYNCHRO GUIDEWIRE (STRYKER); TARGET COIL (STRYKER); ECHELON MICROCATHETER(MEDTRONICS); SYNCHRO GUIDEWIRE (STRYKER); TARGET COIL (STRYKER)
• Patient Age: 52 YR
• Patient Weight: 65