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

Model Number	M0031681900
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that upon deployment of a coil, the physician noticed that the subject microcatheter was behaving strangely and did not have one-to-one feedback.The coil kept kicking the microcatheter out of the aneurysm.When the catheter was removed from the patient's anatomy, the distal portion of the catheter was found broken.The tip of the broken catheter was found inside the guide catheter.Another similar microcatheter was used to complete the procedure without any clinical consequences.
Additional Manufacturer Narrative
D4 - lot/serial no.Corrected to (b)(6).
Event or Problem Description
It was reported that upon deployment of a coil, the physician noticed that the subject microcatheter was behaving strangely and did not have one-to-one feedback.The coil kept kicking the microcatheter out of the aneurysm.When the catheter was removed from the patient's anatomy, the distal portion of the catheter was found broken.The tip of the broken catheter was found inside the guide catheter.Another similar microcatheter was used to complete the procedure without any clinical consequences.
Event or Problem Description
It was reported that upon deployment of a coil, the physician noticed that the subject microcatheter was behaving strangely and did not have one-to-one feedback.The coil kept kicking the microcatheter out of the aneurysm.When the catheter was removed from the patient's anatomy, the distal portion of the catheter was found broken.The tip of the broken catheter was found inside the guide catheter.Another similar microcatheter was used to complete the procedure without any clinical consequences.
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 returned catheter strain relief was found to be detached/separated.A dry blood was noted inside the hub.The catheter shaft was found kinked/bent.During functional testing, the catheter was flushed, and the patency mandrel was advanced through the microcatheter; however, significant resistance was noted, and significant amount of blood exited the microcatheter.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 provided by the customer indicated that there wasn't any damage noted to the packaging prior to opening and 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.It was seen that the catheter shaft was kinked which would account for the difficulty advancing the coil.The catheter tip was intact.The catheter secondary strain relief was detached which may have been perceived as the catheter tip was detached, therefore the as reported defect catheter tip broken/fractured during use was assigned not confirmed.The catheter most likely kinked/bent during the procedure due to some procedural/anatomical factors encountered during use leading to the reported and analyzed defects.Based on the investigation results and available information, an assignable cause of procedural factors was assigned to the as reported defects catheter, difficulty advancing coil, unexpected movement of device as well as analyzed defects catheter shaft kinked/bent, catheter shaft friction and catheter strain relief detached/separated.The product investigation confirmed that the microcatheter tip was found intact and not broken/fractured during use as reported.It is highly unlikely that the detachment of strain relief, kink/bent and friction noted on the microcatheter may contributed to and/or cause any patient injury; therefore, this record has been deemed non-reportable with an awareness date of 18-oct-2021.

• 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: 12316859
• Report Number: 3008881809-2021-00333
• Device Sequence Number: 4136179
• Product Code: DQY
• UDI-Device Identifier: 04546540688224
• UDI-Public: 04546540688224
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 11/05/2021

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: 02/19/2022
• Device Model Number: M0031681900
• Device Catalogue Number: M0031681900
• Device Lot Number: 22164087
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/19/2021
• Supplement Date Received by Manufacturer: 09/08/2021; 10/18/2021
• Initial Report FDA Received Date: 08/12/2021
• Supplement Report FDA Received Date: 09/27/2021; 11/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2020
• 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: BENCHMARK INTRACRANIAL ACCESS CATHETER (PENUMBRA); TARGET COILS (STRYKER); BENCHMARK INTRACRANIAL ACCESS CATHETER (PENUMBRA); TARGET COILS (STRYKER)
• Patient Age: 63 YR
• Patient Sex: Female