MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 8MM X 30CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0036128300
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2021
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 the procedure, a coil was noted to be broken off when attempting to remove the device out of the aneurysm inside the microcatheter.The coil and catheter was removed successfully and replaced with the subject coil and new microcatheter to continue procedure.A similar event in which subject coil had broken off within microcatheter occurred after.Subject coil and microcatheter were removed and procedure was completed successfully with no noted clinical consequences to the patient.No further information.
Additional Manufacturer Narrative
The device was returned within the sl-10 catheter.The lot number was confirmed with the packaging returned with the device.During visual inspection, the proximal contact wire was intact.The coil delivery wire was kinked/bent and the coil was jammed in the catheter shaft.The catheter shaft had to be cut to remove the coil.The main coil snapped when trying to remove the coil and badly stretched.There was blood present in the catheter shaft.During the functional inspection, an attempt to advance the delivery wire in the sl-10 catheter was made but it could not be advanced.The delivery wire was retracted with force in an attempt to remove the coil and the coil snapped when trying to remove from the sl-10 catheter.The remaining coil was jammed in the catheter shaft.The catheter shaft was cut in four sections to remove the coil.Due to the automated manufacturing execution system (mes), there are controls in the manufacturing process to ensure the product met specifications upon release.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 main coil broken fractured was not confirmed during analysis, however it was confirmed that the main coil was jammed in the returned sl-10.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.Additional information received from the customer indicated that continuous flush was maintained throughout the procedure.The patient¿s anatomy was extremely tortuous which may have contributed to the event.The as analyzed coil jammed and main coil stretched will be assigned procedural factors as these defects appear to be associated with a product that met stryker and design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural or anatomical factors during use.The as analyzed coil delivery wire kinked/bent will be assigned handling damage as the issue is due to handling of the product or portion of the product 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.
Event or Problem Description
It was reported that during the procedure, a coil was noted to be broken off when attempting to remove the device out of the aneurysm inside the microcatheter.The coil and catheter was removed successfully and replaced with the subject coil and new microcatheter to continue procedure.A similar event in which subject coil had broken off within microcatheter occurred after.Subject coil and microcatheter were removed and procedure was completed successfully with no noted clinical consequences to the patient.No further information.

• Brand Name: TARGET XL 360 SOFT 8MM X 30CM
• 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: 11283310
• Report Number: 3008881809-2021-00062
• Device Sequence Number: 19903459
• Product Code: HCG
• UDI-Device Identifier: 07613327004649
• UDI-Public: 07613327004649
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 05/12/2021

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: 10/28/2023
• Device Model Number: M0036128300
• Device Catalogue Number: M0036128300
• Device Lot Number: 22528734
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2021
• Initial Date Received by Manufacturer: 01/22/2021
• Supplement Date Received by Manufacturer: 04/27/2021
• Initial Report FDA Received Date: 02/04/2021
• Supplement Report FDA Received Date: 05/12/2021
• 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: EXCELSIOR SL-10 MICROCATHETER (STRYKER)