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

Model Number	M0036115150
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure when the physician advanced coil (subject device) inside the proximal of the microcatheter resistance was encountered.Then the subject coil prematurely detached inside the microcatheter.The detached subject coil was removed along with the microcatheter.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 the procedure when the physician advanced coil (subject device) inside the proximal of the microcatheter resistance was encountered.Then the subject coil prematurely detached inside the microcatheter.The detached subject coil was removed along with the microcatheter.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the coil delivery wire was seen to be kinked bent.The main coil was seen to be detached, the device was returned without the coil.Functional inspection is not required.The reported complaint was confirmed based on the device analysis.The device filed to meet specification when returned, based on the damage noted to the returned device.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.It was reported that during the procedure, the subject coil prematurely detached inside the microcatheter.The device was returned and the main coil had been detached from the delivery wire and the delivery wire was also kinked.It is probable that the main coil was detached within the microcatheter due to procedural or anatomical factors during use.An assignable cause of procedural factors will be assigned to the coil in catheter friction' and main coil prematurely detached/separated during use, as the issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.Coil delivery wire kinked/bent' will be assigned handling damage as this complaint appears to be associated with handling of the product or portion of the product during the procedure, a probable cause of handling damage was assigned.

• Brand Name: TARGET XL HELICAL 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
• MDR Report Key: 12131925
• Report Number: 3008881809-2021-00290
• Device Sequence Number: 3490434
• Product Code: HCG
• UDI-Device Identifier: 07613327004571
• UDI-Public: 07613327004571
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 09/02/2021

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: 07/19/2023
• Device Model Number: M0036115150
• Device Catalogue Number: M0036115150
• Device Lot Number: 22325234
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2021
• Initial Date Received by Manufacturer: 06/14/2021
• Supplement Date Received by Manufacturer: 08/13/2021
• Initial Report FDA Received Date: 07/07/2021
• Supplement Report FDA Received Date: 09/02/2021
• 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 XT-17 MICROCATHETER (STRYKER)