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

Model Number	M0036125150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device not returned for analysis.
Event or Problem Description
It was reported that during coil embolization of acom unruptured aneurysm, the subject coil stretched when attempted to re-position.A gooseneck snare was used to retrieve the coil.The subject device was replaced and the procedure was completed successfully.There were no clinical consequences to the patient.
Additional Manufacturer Narrative
B5 executive summary -updated h4 manufacturing date ¿ added h3 device evaluated by mfg ¿updated h3 summary attached - updated d4 expiration date - added d10 product available to stryker ¿ updated d10 returned to manufacturer on ¿updated d11 concomitant products grid -updated g5 pma/150(k)# -updated h10 additional narrative the device was returned for analysis, and the coil (subject device) was found stretched.The lot number was confirmed with the packaging returned with the device.During visual inspection, the proximal contact wire was intact, and the coil delivery wire was kinked/bent.The distal tip was found to be intact and the main coil was severely stretched.The suture was damaged and the main coil was broken.Functional testing was not required as the the main coil stretched was confirmed during analysis.The device was so badly stretched it could not be inserted into the returned sl-10 catheter.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.Additional information received from the customer that the coil was removed with snare and catheter.In the case of this complaint it is most likely that the main coil stretched during positioning of the coil in the aneurysm.This complaint 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 factors.Therefore an assignable cause of procedural factors will be assigned to the analyzed coil and it is most likely that it stretched due to handling of the device during the procedure.
Event or Problem Description
It was reported that during coil embolization of acom unruptured aneurysm, the coil (subject device) was stretched when the physician attempted to re-position it.The physician used a gooseneck device to retrieve the subject coil.The procedure was completed successfully.There were no clinical consequences to the patient.

• 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 ; IE NA
• MDR Report Key: 9868281
• Report Number: 3008881809-2020-00075
• Device Sequence Number: 561066
• Product Code: HCG
• UDI-Device Identifier: 07613327128291
• UDI-Public: 07613327128291
• Combination Product (Y/N): N
• Initial Reporter Country: JP
• 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): 05/21/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/17/2021
• Device Model Number: M0036125150
• Device Catalogue Number: M0036125150
• Device Lot Number: 21017474
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2020
• Initial Date Received by Manufacturer: 02/26/2020
• Supplement Date Received by Manufacturer: 05/04/2020
• Initial Report FDA Received Date: 03/23/2020
• Supplement Report FDA Received Date: 05/21/2020
• 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: MICROCATHETER SL-10 (STRYKER); SL-10 CATHETER (STRYKER); SNARE (UNKNOWN)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR