MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET HELICAL ULTRA 3MM X 6CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035433060
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the coil (subject device) could not be detached after it was advanced into lumen of aneurysm.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.The coil (subject device) was returned for analysis and it was discovered that the coil (subject device) delivery wire was broken/fractured during use.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
Due to the automated mes (manufacturing execution system) system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the coil delivery wire was seen to be kinked/bent, the coil delivery wire was seen to be broken just beyond the coil proximal junction,(proximal contact not returned), and the main coil was intact.A functional test was not carried out due to a break on the coil deliver wire.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 main coil failed/unable to detach could not be confirmed; however, the analysis results are consistent with the reported event.Although functional testing did not confirm the coil detachment during analysis, the damage noted during analysis of the detached proximal contact is indicative of the reported detachment failure.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.Additional information provided by the customer was the coil could not be detached.It was reported that 3 attempts were made to detach the coil, it was also reported that proximal end of the delivery wire was not wiped with alcohol prior to inserting into the in-zone, this is a requirement step within the supplied dfu and as it was not completed it may have been a contributing factor to the reported detachment failure.It was also reported that there was no damage noted to the packaging prior to opening and the device was confirmed to be in good condition during preparation/prior to use on the patient, and that continuous flush was set up and maintained during the procedure.During analysis, the coil delivery wire was found to be kinked/bent and broken.The proximal end of the delivery wire was not returned.The coil was found to be intact during device analysis.In the case of this complaint it is likely that the delivery wire was damaged due to handling when inserting the device into the in- zone.Therefore, the as reported 'main coil failed/unable to detach' as well as the as analyzed 'coil delivery wire kinked/bent' and 'coil delivery wire broken/fractured during use' 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.

• Brand Name: TARGET HELICAL ULTRA 3MM X 6CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 15376284
• Report Number: 3008881809-2022-00439
• Device Sequence Number: 5648349
• Product Code: HCG
• UDI-Device Identifier: 04546540676078
• UDI-Public: 04546540676078
• 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
• Report Date (Section B): 09/08/2022

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: 10/04/2024
• Device Model Number: M0035433060
• Device Catalogue Number: M0035433060
• Device Lot Number: 23197947
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/24/2022
• Initial Report FDA Received Date: 09/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/06/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ATLAS STENT (STRYKER); AXIUM COIL (NON-STRYKER); SL-10 CATHETER (STRYKER); SYNCHRO GUIDEWIRE (STRYKER); TARGET COIL (STRYKER)
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Race: Asian