MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 STANDARD 7MM X 20CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0036107200
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.The device was returned with a catheter.The lot number was not confirmed as the packaging was not returned.During visual inspection, the coil delivery wire was not returned, the main coil was detached, and the distal tip was found to be intact.The main coil was severely stretched, and the suture was damaged.Functional testing was not carried out as the coil was returned detached.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 device was returned for analysis and the coil was found stretched, suture was damaged and prematurely detached.In the case of this complaint, it is most likely that anatomical or procedural factors resulted in the subject coil stretched, damaged suture and eventually detached when trying to remove.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 during use.Therefore, an assignable cause of procedural factors will be assigned to the as reported and as analyzed events.
Event or Problem Description
It was reported that during the procedure the subject coil was inserted into the microcatheter while doing so it got stuck and was unable to be pushed or pulled.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.Analysis of the device revealed that the main coil had prematurely deployed; therefore, based on this information the event is deemed reportable and emdr will be filed with an aware date of 25-jun-2020.The event will be assessed to reflect the decision change and emdr will be filed accordingly.

• Brand Name: TARGET XL 360 STANDARD 7MM X 20CM
• 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: 10271277
• Report Number: 3008881809-2020-00203
• Device Sequence Number: 824569
• Product Code: HCG
• UDI-Device Identifier: 07613327004762
• UDI-Public: 07613327004762
• 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
• Report Date (Section B): 07/14/2020

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: 05/20/2022
• Device Model Number: M0036107200
• Device Catalogue Number: M0036107200
• Device Lot Number: 21468631
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/25/2020
• Initial Report FDA Received Date: 07/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1