MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 6MM X 20CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0036126200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device not returned.
Event or Problem Description
It was reported that the first subject coil was used to create a frame in the target site.Without detaching the first coil, the physician then placed 5 to 6 coils to the target site.The physician tried to detach the subject coil once the framing was stable; however, the coil was not able to be detached.The detachment system was replaced, but still the coil could not be detached.To remove the coil from the patient¿s anatomy, the physician collected the subject coil while holding it with the balloon catheter during this time the coil became stretched and a gooseneck snare was used to remove it from the patient¿s anatomy.Another coil was used to complete the procedure successfully.No clinical consequences were reported 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.Visual and functional testing was not performed since the device was not returned.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.As the product was not returned and review and analysis of all available information fails to indicate an assignable cause or probable assignable cause for the reported event, an assignable cause of undeterminable will be assigned to this complaint.
Event or Problem Description
It was reported that the first subject coil was used to create a frame in the target site.Without detaching the first coil, the physician then placed 5 to 6 coils to the target site.The physician tried to detach the subject coil once the framing was stable; however, the coil was not able to be detached.The detachment system was replaced, but still the coil could not be detached.To remove the coil from the patient¿s anatomy, the physician collected the subject coil while holding it with the balloon catheter during this time the coil became stretched and a gooseneck snare was used to remove it from the patient¿s anatomy.Another coil was used to complete the procedure successfully.No clinical consequences were reported due to this event.

• Brand Name: TARGET XL 360 SOFT 6MM X 20CM
• 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: 11266785
• Report Number: 3008881809-2021-00059
• Device Sequence Number: 2590316
• Product Code: HCG
• UDI-Device Identifier: 07613327004625
• UDI-Public: 07613327004625
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K153658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2021

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: 08/17/2022
• Device Model Number: M0036126200
• Device Catalogue Number: M0036126200
• Device Lot Number: 21651819
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/07/2021
• Supplement Date Received by Manufacturer: 03/11/2021
• Initial Report FDA Received Date: 02/02/2021
• Supplement Report FDA Received Date: 04/05/2021
• 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: BALLOON CATHETER (UNKNOWN MANUFACTURER); GOOSENECK SNARE ( UNKNOWN MANUFACTURER); INZONE DETACHMENT SYSTEM (STRYKER); BALLOON CATHETER (UNKNOWN MANUFACTURER); GOOSENECK SNARE ( UNKNOWN MANUFACTURER); INZONE DETACHMENT SYSTEM (STRYKER)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 89 YR