MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET HELICAL ULTRA 2.5MM X 6CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035432560
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device is not available to the manufacturer.
Event or Problem Description
It was reported that during aneurysm embolization case, the subject coil was already placed and successfully detached inside the aneurysm and when the physician tried to remove a different coil outside of patient's anatomy, the subject coil migrated unexpectedly and came outside the patient's anatomy along with the other coil.The physician used new coils to complete the procedure successfully.There were no reported clinical consequences to the patient.
Event or Problem Description
It was reported that during aneurysm embolization case, the subject coil was already placed and successfully detached inside the aneurysm and when the physician tried to remove a different coil outside of patient's anatomy, the subject coil migrated unexpectedly and came outside the patient's anatomy along with the other coil.The physician used new coils to complete the procedure successfully.There were no reported clinical consequences to the patient.
Additional Manufacturer Narrative
D4: expiration date ¿ added.D9/h3: product available to stryker ¿ updated.D9: returned to manufacturer on ¿updated.C2/d10: concomitant product grid ¿ added.H3: device evaluated by mfg ¿updated.H3: summary attached ¿ updated.H4: manufacturing date ¿ added.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the main coil noted to be detached from the pusher wire.The main coil was also seen to be kinked/bent and stretched.Functional testing was not performed as the coil was already detached when 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 reported event was confirmed based on the analysis.As stated in the event description, the coil was successfully deployed but was pulled back when the partner coil was retracted.It is most likely the main coil stretched and kinked/bent when the partner coil was retracted.An assignable cause of caused by other was assigned to the as reported and as analyzed issues.This is 1st of 2 reports.

• Brand Name: TARGET HELICAL ULTRA 2.5MM X 6CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; IE NA
• MDR Report Key: 10099411
• Report Number: 3008881809-2020-00159
• Device Sequence Number: 3407510
• Product Code: HCG
• UDI-Device Identifier: 04546540676054
• UDI-Public: 04546540676054
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• 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): 07/31/2020

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: 06/19/2021
• Device Model Number: M0035432560
• Device Catalogue Number: M0035432560
• Device Lot Number: 20621210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2020
• Initial Date Received by Manufacturer: 05/11/2020
• Supplement Date Received by Manufacturer: 07/12/2020
• Initial Report FDA Received Date: 05/28/2020
• Supplement Report FDA Received Date: 07/31/2020
• 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: EXCELSIOR SL-10 MICRO CATHETER(STRYKER); TARGET HELICAL ULTRA 2.5MM X 6CM(STRYKER)
• Patient Age: 40 YR
• Patient Weight: 80