MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK EXCELSIOR SL-10 PRE-SHAPED 45 150CM; CATHETER, PERCUTANEOUS

Model Number	M0031681900
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	07/04/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an embolism procedure, a detachment device was used in attempt to detach a coil after aligning the markers.After 3 cycles, the delivery wire was pulled, but the coil came along with it.The marker was aligned again and the detachment attempt of the coil was performed again and the delivery wire was pulled.However, the coil was still attached to its delivery wire and was not detached but was stuck inside the subject microcatheter.An attempt was made to remove the microcatheter (subject device) from the patient¿s anatomy but was unsuccessful.The subject microcatheter was tangled and was stuck with the already deployed coil mass inside the aneurysm.Two guidewires were used as medical intervention to remove the microcatheter (subject device) from the coil mass but was also unsuccessful.Finally, the subject microcatheter was removed by inflating additional balloon catheter.Additional force was applied to remove the subject microcatheter while the balloon catheter was being inflated.When removed, the stuck coil was found at the tip of the subject 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 an embolism procedure, a detachment device was used in attempt to detach a coil after aligning the markers.After 3 cycles, the delivery wire was pulled, but the coil came along with it.The marker was aligned again and the detachment attempt of the coil was performed again and the delivery wire was pulled.However, the coil was still attached to its delivery wire and was not detached but was stuck inside the subject microcatheter.An attempt was made to remove the microcatheter (subject device) from the patient¿s anatomy but was unsuccessful.The subject microcatheter was tangled and was stuck with the already deployed coil mass inside the aneurysm.Two guidewires were used as medical intervention to remove the microcatheter (subject device) from the coil mass but was also unsuccessful.Finally, the subject microcatheter was removed by inflating additional balloon catheter.Additional force was applied to remove the subject microcatheter while the balloon catheter was being inflated.When removed, the stuck coil was found at the tip of the subject microcatheter.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
¿ d4 expiration date - added.¿ h4 manufacturing date ¿ added.¿ h3 device evaluated by mfg ¿updated.¿ h3 summary attached - updated.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.During the visual inspection, the main coil was found to stuck inside the microcatheter and the microcatheter was found to be intact.During the functional inspection, a catheter-coil jammed, functional device interaction with other device, and catheter friction functional tests were performed.The catheter was flushed, and the patency mandrel was advanced through the catheter to pushed out the jammed coil.Before coil was advanced the blood was found to exit the catheter tip.There was no friction noted during the test 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 per additional information the device was prepared for use as per the directions for use, the device was confirmed to be in good condition during preparation/prior to use on the patient and continuous flush was maintained throughout the clinical procedure.Also additional information indicated that a medical intervention was required and a balloon was inflated and the surgeon held coil mass down and forced to pull out the microcatheter.The device was returned for analysis, and coil was found jammed in the catheter shaft.The removed coil was badly damaged which may have contributed to the event.Blood exited the catheter shaft when advancing the coil.Therefore an assignable cause of procedural factors will be assigned to the as reported and as analyzed catheter, coil jammed and to as reported device interaction with another device, catheter friction and patient medical or surgical intervention required.

• Brand Name: EXCELSIOR SL-10 PRE-SHAPED 45 150CM
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 12236297
• Report Number: 3008881809-2021-00315
• Device Sequence Number: 4448370
• Product Code: DQY
• UDI-Device Identifier: 04546540688224
• UDI-Public: 04546540688224
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K042568
• 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): 11/08/2021

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: 12/14/2022
• Device Model Number: M0031681900
• Device Catalogue Number: M0031681900
• Device Lot Number: 22644409
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/05/2021
• Supplement Date Received by Manufacturer: 10/12/2021
• Initial Report FDA Received Date: 07/28/2021
• Supplement Report FDA Received Date: 11/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/15/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ASASHI CHIKAI GUIDEWIRE (ASAHI INTECC MEDICAL); CHIKAI BLACK GUIDEWIRE (ASAHI INTECC MEDICAL); INZONE (STRYKER); TARGET 360 NANO 2MM X 4CM COIL (STRYKER); TRANSFORM BALLOON CATHETER (STRYKER); ASASHI CHIKAI GUIDEWIRE (ASAHI INTECC MEDICAL); CHIKAI BLACK GUIDEWIRE (ASAHI INTECC MEDICAL); INZONE (STRYKER); TARGET 360 NANO 2MM X 4CM COIL (STRYKER); TRANSFORM BALLOON CATHETER (STRYKER)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Patient Race: Asian