MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK EXCELSIOR 1018 STRAIGHT 1 TIP 150CM; CATHETER, PERCUTANEOUS

Model Number	M0031441810
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, when the microcatheter (subject device) was placed in the external carotid artery and the imaging was confirmed, a contrast agent was found to be leaking approximately 5 cm from the tip of the microcatheter (subject device).The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
The device is not available to the manufacturer.
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) system 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 kinked/bent at 13cm, 120cm, 117cm and 149cm from the hub.The catheter was found to be flat/crushed 1.5cm from the tip.The catheter hub was intact.During functional inspection the catheter was flushed and fluid leaked approximately 5 cm from the tip.There was a scratch identified around this area and a small hole was seen.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 dfu, there was no damages 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 flush was given to the catheter prior to guidewire insertion.Also, additional information provided indicated that flush was given inside the microcatheter when inserting the guidewire and there was no reported leak.When the subject microcatheter was placed in the external carotid artery and when the imaging was confirmed, contrast agent was found to be leaked from approximately 5 cm from the tip of the microcatheter.The procedure was completed as it was.The catheter shaft was found to be kinked, flattened and damaged.The catheter shaft leaked during analysis, confirming the event.The catheter shaft may have become damaged during preparation or the procedure due to some procedural factors.The as reported catheter shaft leak during use as well as the as analyzed catheter shaft kinked/bent, catheter shaft flat/crushed, catheter shaft leak during use, catheter shaft has hole/perforation and catheter shaft damaged will be assigned procedural factors as issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.
Event or Problem Description
It was reported that during the procedure, when the microcatheter (subject device) was placed in the external carotid artery and the imaging was confirmed, a contrast agent was found to be leaking approximately 5 cm from the tip of the microcatheter (subject device).The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: EXCELSIOR 1018 STRAIGHT 1 TIP 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: 16278006
• Report Number: 3008881809-2023-00049
• Device Sequence Number: 15171252
• Product Code: DQY
• UDI-Device Identifier: 04546540688118
• UDI-Public: 04546540688118
• 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): 04/26/2023

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: 04/20/2025
• Device Model Number: M0031441810
• Device Catalogue Number: M0031441810
• Device Lot Number: 23604371
• 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: 01/30/2023
• Supplement Date Received by Manufacturer: 03/31/2023
• Initial Report FDA Received Date: 02/01/2023
• Supplement Report FDA Received Date: 04/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2022
• 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