MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 6MM X 30CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035476300
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unruptured pcom aneurysm case the subject coil was deployed as the first coil.The subject coil was unable to maintain its shape and was not framing properly.The physician tried to adjust the subject coil but it got stretched inside the aneurysm.He then decided to remove the subject coil from the catheter but it broke inside the patient.Some of it was in the aneurysm the rest was taken out.The physician replaced it with a new device and completed the procedure with some more coils and stent.Patient's anatomy was moderately tortuous and there was no clinical consequences to the patient.
Event or Problem Description
It was reported that during an unruptured pcom aneurysm case the subject coil was deployed as the first coil.The subject coil was unable to maintain its shape and was not framing properly.The physician tried to adjust the subject coil but it got stretched inside the aneurysm.He then decided to remove the subject coil from the catheter but it broke inside the patient.Some of it was in the aneurysm the rest was taken out.The physician replaced it with a new device and completed the procedure with some more coils and stent.Patient's anatomy was moderately tortuous and there was no 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 the visual inspection, the coil delivery wire was found to be kinked/bent.The main coil was found to be broken off from the delivery wire.The coil delivery wire was found to be damaged.The main coil was not returned.Functional testing was not performed as the coil was not returned.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 coil delivery wire was found to be kinked/bent, the main coil was found to be broken off from the delivery wire and the coil delivery wire was found to be damaged.An assignable cause of procedural factors will be assigned to the as reported / as analyzed 'main coil broken/fractured during use', as reported 'main coil loss of memory' and 'main coil stretched' as these defects are 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 and/or anatomical factors during use.An assignable cause of handling damage will be assigned to as analyzed 'coil delivery wire kinked/bent' and 'coil delivery wire damaged' since it is most likely that this damage occurred due to handling of delivery wire during the clinical procedure.

• Brand Name: TARGET 360 SOFT 6MM X 30CM
• 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: 11969954
• Report Number: 3008881809-2021-00236
• Device Sequence Number: 17246946
• Product Code: HCG
• UDI-Device Identifier: 04546540676559
• UDI-Public: 04546540676559
• 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): 09/13/2021

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: M0035476300
• Device Catalogue Number: M0035476300
• Device Lot Number: 22014692
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2021
• Initial Date Received by Manufacturer: 05/17/2021
• Supplement Date Received by Manufacturer: 08/24/2021
• Initial Report FDA Received Date: 06/09/2021
• Supplement Report FDA Received Date: 09/13/2021
• 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: EXCELSIOR SL-10 MICRO CATHETER (STRYKER); EXCELSIOR XT- 27 MICRO CATHETER (STRYKER); NEUROFORM STENT (STRYKER); SYNCHRO GUIDE WIRE (STRYKER); TARGET COILS (STRYKER)
• Patient Age: 67 YR