MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK EXCELSIOR SL-10 PRE-SHAPED 90 150CM; CATHETER, PERCUTANEOUS

Model Number	M0031681910
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 other text : the device is not available to the manufacturer.
Event or Problem Description
It was reported that during a stroke procedure the subject microcatheter broke spontaneously into two pieces at the junction of the rhv and 3-way, so inside the flushing system.The subject device was removed and replaced.There was a surgical delay but the procedure was completed successfully.No further information is available.
Additional Manufacturer Narrative
B5: executive summary- updated.H4: manufacturing date ¿ added.H3: device evaluated by mfg ¿updated.H3: summary attached - updated.D4: expiration date - added.D9: product available to stryker- updated.D9: returned to manufacturer on- updated.G4: pma/510(k) or bla # - corrected.Due to the automated manufacturing execution system (mes) there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the catheter shaft was seen to be broken 28cm from the catheter hub.The catheter shaft was seen to be kinked/bent 21 and 28 cm from the catheter tip.The catheter tip and hub were intact.A functional inspection was not required as the catheter was visually damaged.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.The reported complaint was confirmed based on analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.Additional information provided by the customer indicated that the device was prepared for use as per the directions for use, 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 and continuous flush was set up and maintained throughout the clinical procedure.Also additional information indicated there was resistance removing the device from the packaging.The catheter shaft was kinked and was found to be fractured.The catheter may have been damaged during removal from the packaging tray, which may have contributed to the fracture during the procedure.The reported and analyzed defect catheter shaft broken/fractured during use and the reported catheter difficult to remove/withdraw from dispenser coil as well as the analyzed defect catheter shaft kinked/bent will be assigned handling damage as the issue is due to handling of the product or portion of the product during the clinical procedure, upon removal of the product from the packaging.
Event or Problem Description
It was reported that during a stroke procedure the subject microcatheter broke spontaneously into two pieces at the junction of the rhv and 3-way, so inside the flushing system.The subject device was removed and replaced.There was a surgical delay but the procedure was completed successfully.No further information is available.Additional information received on 21st apr 2023, stated that there was a surgical delay of 20 minutes.

• Brand Name: EXCELSIOR SL-10 PRE-SHAPED 90 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: 16781007
• Report Number: 3008881809-2023-00194
• Device Sequence Number: 6709408
• Product Code: DQY
• UDI-Device Identifier: 04546540688231
• UDI-Public: 04546540688231
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 05/31/2023

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: 11/21/2024
• Device Model Number: M0031681910
• Device Catalogue Number: M0031681910
• Device Lot Number: 24023968
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/27/2023
• Supplement Date Received by Manufacturer: 05/24/2023
• Initial Report FDA Received Date: 04/20/2023
• Supplement Report FDA Received Date: 05/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/23/2022
• 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
• Patient Sex: Unknown