MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK EXCELSIOR 1018 PRE-SHAPED 45 150CM; CATHETER, PERCUTANEOUS

Catalog Number	M0031441900
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2024
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 an endovascular procedure saline solution leaked from the strain relief area of the subject microcatheter.After that, subject microcatheter was replaced with another microcatheter and completed the procedure successfully.
Additional Manufacturer Narrative
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.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 kinked 115cm from the proximal of the hub.The catheter hub was intact.During functional inspection, the catheter was flushed, and the water exited the catheter tip and below the hub.The leak was coming from beneath the strain relief.The strain relief was removed, the shaft was cut.There was a leak identified.The location of the cut and where the leak was coming from was measured.There was procedural fluid on the catheter shaft below the hub.The strain relief was intact.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 and there were no damages noted to the packaging prior to opening the packaging.Also, additional information provided indicated after catheter was delivered to the target vessel, the delivery wire was removed.When negative pressure was applied to catheter with a syringe, saline solution leaked from the strain relief area and was removed.Also, additional information provided indicated there were no blades or sharps in the preparation area or used during the procedure.During analysis the returned catheter was flushed, and a leak was coming from beneath the primary strain relief.To determine where the leak was coming from - the primary strain relief was removed to allow a visual examination of the proximal shaft.There was a cut on the complaint unit going through the catheter shaft.The quality/ engineering line support for excelsior 1018 viewed the unit and confirmed the issue.An assignable cause of manufacturing will be assigned to the as reported and analyzed 'catheter shaft leak during use' as well as the as analyzed 'catheter shaft has hole/perforation', as this is an issue in which product fails to meet specification due to the manufacturing process at a stryker neurovascular manufacturing site.The as analyzed '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.
Event or Problem Description
It was reported that during an endovascular procedure saline solution leaked from the strain relief area of the subject microcatheter.After that, subject microcatheter was replaced with another microcatheter and completed the procedure successfully.

• Brand Name: EXCELSIOR 1018 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: 18857250
• Report Number: 3008881809-2024-00095
• Device Sequence Number: 8240184
• Product Code: DQY
• UDI-Device Identifier: 04546540688132
• UDI-Public: 04546540688132
• 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): 05/14/2024

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: 05/27/2025
• Device Catalogue Number: M0031441900
• Device Lot Number: 24348976
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/22/2024
• Supplement Date Received by Manufacturer: 05/03/2024
• Initial Report FDA Received Date: 03/07/2024
• Supplement Report FDA Received Date: 05/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2023
• 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: C-STOPPER COIL (PIOLAX); ESTREAM MICROCATHETER (TOKAI MEDICAL); MEISTER GUIDEWIRE (ASAHI INTEC); NESTER COIL (COOK MEDICAL)
• Patient Sex: Male