MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 5MM X 15CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0036125150
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2021
Type of Reportable Event	Malfunction
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 analysis, the coil delivery wire was seen to be kinked/bent and the main coil was found to be prematurely detached/separated during use.Functional testing could not be performed as the coil was not returned.The reported event could not be confirmed; however, the analysis results are consistent with the reported event.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.Additional information received from the customer indicated that continuous flush was not maintained throughout the procedure and an incompatible non-stryker microcatheter was used, which is likely to have caused the user to experience friction and contributed to the product problem codes noted.Additional information received from the customer indicated that continuous flush was not maintained throughout the procedure and an incompatible non-stryker microcatheter (0.021 in) was used, which is likely to have caused the user to experience friction and contributed to the product problem codes noted.The dfu states continuous flush is to be maintained throughout the procedure and "target detachable coils are compatible with stryker neurovascular 2-tip marker microcatheters (min.Internal diameter 0.41 mm [0.016 in], max.Internal diameter 0.48 mm [0.019 in]).".Therefore, based on the current information available, the as reported issue of 'coil in catheter friction' and as analyzed ' main coil prematurely detached/separated during use' will be assigned 'user error'.An assignable cause of handling damage will be assigned to the 'coil delivery wire kinked/bent' as it is most likely that this damage to the delivery wire occurred due to handling of the device during use.
Event or Problem Description
It was reported that during procedure when the subject coil deployment operation was performed in the blood vessel, resistance was felt at the middle part and could not be used.The physician removed the subject coil and replaced it with another coil.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.Analysis of the returned device found the main coil prematurely detached/separated during use.There were no clinical consequences to the patient reported as a result of this event.

• Brand Name: TARGET XL 360 SOFT 5MM X 15CM
• 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: 12278609
• Report Number: 3008881809-2021-00324
• Device Sequence Number: 11912108
• Product Code: HCG
• UDI-Device Identifier: 07613327128291
• UDI-Public: 07613327128291
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 08/04/2021

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: 09/17/2023
• Device Model Number: M0036125150
• Device Catalogue Number: M0036125150
• Device Lot Number: 22438604
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/28/2021
• Initial Report FDA Received Date: 08/04/2021
• 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: MICROCATHETER (NON STRYKER MANUFACTURER)