MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 STANDARD 10MM X 40CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0036101040
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record confirms that the device met all material, assembly and performance specifications.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.Visual examination of the returned device found that the main coil was returned manually detached.The coil delivery wire was kinked/bent.Functional testing could not be performed due as the main coil was returned detached.Analyzing of the device found the device main coil already mechanically detached from the delivery wire.Based on the investigation and the available information, it is probable that the delivery wire was kinked due to improper handling of the device during the clinical procedure, possibly when inserting the proximal end into the inzone.This likely resulted in the reported detachment issue.It is probable that after unsuccessful detachment, the main coil was withdrawn with force through the microcatheter and mechanically detached.Therefore, an assignable cause of handling damage had been assigned to the observed coil detachment and the coil delivery wire bent/kinked as the issue is due to handling of the device or portion of the device during the clinical procedure.
Event or Problem Description
Analysis of the returned device found the coil (subject device) prematurely detached inside the patient during the procedure.There were no clinical consequences to the patient.

• Brand Name: TARGET XL 360 STANDARD 10MM X 40CM
• 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: 9929557
• Report Number: 3008881809-2020-00088
• Device Sequence Number: 19416654
• Product Code: HCG
• UDI-Device Identifier: 04546540711274
• UDI-Public: 04546540711274
• Combination Product (Y/N): N
• Initial Reporter Country: DE
• PMA/510(K) Number: K161429
• 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): 04/06/2020

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: 01/23/2022
• Device Model Number: M0036101040
• Device Catalogue Number: M0036101040
• Device Lot Number: 21152881
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/16/2020
• Initial Report FDA Received Date: 04/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1