MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 16MM X 50CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0036121650
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received and the reported lot number was confirmed from the packaging label.On visual/microscopic inspection, the coil delivery wire was seen to be kinked/bent.The proximal contact and coil delivery wire was seen to be broken.The distal end of the delivery wire or the coil was not returned.Functional inspection was not carried out due to damage.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.The product was returned and the reported event could not be confirmed; however, the analysis results are consistent with the reported event.The device did not meet specifications when received for complaint investigation based on functional and visual inspection.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.Thus, the as reported ¿main coil failed/unable to detach¿ will be assigned as not confirmed.It can be presumed that the coil delivery wire and proximal contact were damaged during the procedure.The defect appears to be associated with handling of the product or portion of the product during the procedure/upon removal of the product from the packaging/preparation of the product prior to use, a probable cause of handling damage will be assigned to as analyzed code 'coil delivery wire kinked/bent¿, 'coil proximal contact wire broken/fractured' and 'coil delivery wire broken/fractured during use'.
Event or Problem Description
The subject coil was returned for analysis and it was discovered that the coil delivery wire broken/fractured during use.There was no clinical consequence to the patient reported as a result of this event.

• Brand Name: TARGET XL 360 SOFT 16MM X 50CM
• 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: 13312408
• Report Number: 3008881809-2022-00030
• Device Sequence Number: 17324933
• Product Code: HCG
• UDI-Device Identifier: 04546540711557
• UDI-Public: 04546540711557
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 01/21/2022

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: 10/12/2023
• Device Model Number: M0036121650
• Device Catalogue Number: M0036121650
• Device Lot Number: 22496069
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/30/2021
• Initial Report FDA Received Date: 01/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/13/2020
• 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
• Patient Sex: Female