MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 STANDARD 18MM X 50CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036101850
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/28/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the coil (subject device) was stretched while being inserted into the micro catheter and the snare system was used to collect the stretched coil.There were no reported clinical consequences to the patient.
Additional Manufacturer Narrative
Expiration date - added.Device evaluated by mfg - updated.Summary attached - updated.Manufacturing date ¿ added.The device history record confirms that the device met all material, assembly and performance specifications.The device was returned with an unidentified catheter.Visual inspection revealed that the coil delivery wire was kinked/bent, the main coil was returned as detached from the main coil and the main coil was stretched.The coil delivery wire was found to kinked as well, likely due to handling.The functional analysis of the returned device was not required since the reported events were confirmed through analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.Due to the automated mes system 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 main coil was stretched and was observed to be detached from the pusher wire.This could have been caused when the coil was being advanced against friction or else when it was being removed by snare through the catheter where the medical intervention would have taken place.The reported event of appears 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.Therefore, an assignable cause of procedural factors was assigned to as reported event of patient medical intervention and observed damages.
Event or Problem Description
It was reported that the coil(subject device) was stretched while being inserted into the micro catheter and the snare system was used to collect the stretched coil.There were no reported clinical consequences to the patient.

• Brand Name: TARGET XL 360 STANDARD 18MM X 50CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 9042020
• Report Number: 3008881809-2019-00273
• Device Sequence Number: 2223248
• Product Code: HCG
• UDI-Device Identifier: 07613327004724
• UDI-Public: 07613327004724
• Combination Product (Y/N): N
• 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): 11/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/19/2022
• Device Catalogue Number: M0036101850
• Device Lot Number: 21304764
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2019
• Initial Date Received by Manufacturer: 08/28/2019
• Supplement Date Received by Manufacturer: 10/31/2019
• Initial Report FDA Received Date: 09/13/2019
• Supplement Report FDA Received Date: 11/08/2019
• 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 MICROCATHETER(STRYKER).
• Outcome Attributed to Adverse Event: Required Intervention