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

Model Number	M0036125150
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that during procedure the coil (subject device) broke off inside the catheter.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Event or Problem Description
It was reported that during procedure the coil (subject device) broke off inside the catheter.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
Section b1 adverse event/product problem - corrected - no product problem.Section h1 type of reportable event - corrected - no malfunction.H4 manufacturing date ¿ added.H3 device evaluated by mfg ¿updated.H3 summary attached - updated.D4 expiration date - added.D9 product available to stryker ¿ updated.D9 returned to manufacturer on ¿updated.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 device was returned stuck in a non-stryker catheter, the main coil was seen to be protruding out of the distal end of the non-stryker catheter, the main coil was seen to be kinked/bent and stretched.No breakage noted, and the coil delivery wire was seen to be kinked/bent.During a functional test, the device was stuck in a non-stryker catheter and, despite efforts made, could not be retracted or pushed through the catheter.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 complaint was not confirmed based on analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.During analysis, the main coil was found to be stuck inside the microcatheter.The coil was found to be kinked/bent and stretched; however, there was no breakage noted.An assignable cause of procedural factors will be assigned to the analyzed ¿main coil stretched¿, ¿main coil kinked/bent¿, and ¿moil jammed¿ as the defects are associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu but performance was limited due to procedural and/or anatomical factors during use.An assignable code of not confirmed will be assigned to the reported 'main coil broken/fractured during use' as the defect was not confirmed during the analysis.An assignable cause of handling damage will be assigned to the analyzed 'coil delivery wire kinked/bent' since it is most likely that this damage occurred due to handling of delivery wire during the clinical procedure.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.

• 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
• 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: 15070861
• Report Number: 3008881809-2022-00362
• Device Sequence Number: 5489421
• Product Code: HCG
• UDI-Device Identifier: 07613327128291
• UDI-Public: 07613327128291
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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): 09/21/2022

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: 02/13/2025
• Device Model Number: M0036125150
• Device Catalogue Number: M0036125150
• Device Lot Number: 23474783
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/05/2022
• Supplement Date Received by Manufacturer: 09/16/2022
• Initial Report FDA Received Date: 07/20/2022
• Supplement Report FDA Received Date: 09/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2022
• 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: PHENOM 17 MICROCATHETER (NON-STRYKER)
• Patient Sex: Unknown