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

Model Number	M0031681900
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/31/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is 2 of the 2 reports.
Event or Problem Description
It was reported that during an a-com cerebral aneurysm coil embolization procedure, physician inserted the subject catheter into the aneurysm using the jailed balloon technique and embolization was performed after placing a stent.He tried to change the position of the subject catheter using the guidewire and tried to re-insert the subject catheter into the aneurysm using trans cell technique.When the guidewire was removed it was seen that the coating was peeled off.It wasn't confirmed if the peeling was of the subject catheter or the guidewire.There might be some coating fragments left inside the patients anatomy.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.No additional information available.
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 subject device is not available; therefore, visual and functional testing cannot be performed.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 was no damage noted to the packaging prior to opening the packaging, the device was confirmed to be in good condition during preparation/prior to use on the patient, the device was prepared as per dfu(direction for use), flush was given when the microcatheter when taken out from the dispenser hoop and continuous flush was set up and maintained throughout the clinical procedure.Only the syringe with coating-like material was returned.The color of the coating material peeled off was dark bluish color.It is possible peeled material may be present in patient¿s anatomy.It is unknown at present if the patient was affected as a result of the event."no health hazards have been identified at this time, but if the collected material is a microcatheter or guidewire coating, it may cause embolism".The patient¿s current condition is unknown.Product analysis for the concurrent synchro guidewire found slivers of ptfe returned inside a syringe.The type of peeling noted is consistent with damage caused by back loading the synchro guidewire into the introducer sheath.However, since the sl-10 microcatheter and the concurrent synchro guidewire was not returned for analysis this could not be definitively assessed.While it is possible peeled material may be present in patient¿s anatomy, this has not been confirmed and remains currently unknown.Therefore, a cause of undeterminable has been assigned to the as reported 'ptfe inner lining peeling ' and 'un-retrieved device fragments¿.
Event or Problem Description
It was reported that during an a-com cerebral aneurysm coil embolization procedure, physician inserted the subject catheter into the aneurysm using the jailed balloon technique and embolization was performed after placing a stent.He tried to change the position of the subject catheter using the guidewire and tried to re-insert the subject catheter into the aneurysm using trans cell technique.When the guidewire was removed it was seen that the coating was peeled off.It wasn¿t confirmed if the peeling was of the subject catheter or the guidewire.There might be some coating fragments left inside the patients anatomy.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.No additional information available.

• 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: 12531198
• Report Number: 3008881809-2021-00397
• Device Sequence Number: 1140157
• 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): 01/10/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/12/2023
• Device Model Number: M0031681900
• Device Catalogue Number: M0031681900
• Device Lot Number: 22680947
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/31/2021
• Supplement Date Received by Manufacturer: 12/20/2021
• Initial Report FDA Received Date: 09/27/2021
• Supplement Report FDA Received Date: 01/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/13/2021
• 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: NEUROFORM ATLAS STENT (STRYKER; SYNCHRO 2 GUIDEWIRE (STRYKER); UNKNOWN BALLOON; UNKNOWN COILS; NEUROFORM ATLAS STENT (STRYKER; SYNCHRO 2 GUIDEWIRE (STRYKER); UNKNOWN BALLOON; UNKNOWN COILS
• Outcome Attributed to Adverse Event: Other
• Patient Age: 33 YR
• Patient Sex: Female