MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY TREVO PRO 18 MICROCATHETER 150CM; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	90238
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an acute thrombectomy case, when the physician attempted to build access with the support of a guidewire, the distal of the subject catheter kinked and eventually fractured while being delivered into the patient.The device was removed with the guidewire and replaced.The procedure was completed successfully with no clinical consequences to the patient due to this event.
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that during an acute thrombectomy case, when the physician attempted to build access with the support of a guidewire, the distal of the subject catheter kinked and eventually fractured while being delivered into the patient.The device was removed with the guidewire and replaced.The procedure was completed successfully with no clinical consequences to the patient due to this event.
Additional Manufacturer Narrative
H4 manufacturing date ¿ added d4 expiration date ¿ added due to the automated mes 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 as well as physical analysis cannot be performed.The reported complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.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 the device was confirmed to be in good condition during preparation/prior to use on the patient and was prepared as per the dfu, continuous flush was set up and maintained throughout the clinical procedure, the patient's anatomy was not tortuous, a retriever was used in conjunction with the subject device, the fracture occurred during delivery inside the patient, and there was no resistance encountered during the procedure.While there are a number of potential causes for the reported issue, because review of available information failed to identify a definitive cause and the device was not returned for analysis, an assignable cause of undeterminable was assigned to the reported events 'catheter tip broken/fractured during use' and 'catheter tip kinked/bent'.

• Brand Name: TREVO PRO 18 MICROCATHETER 150CM
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY; 4870 west 2100 south; salt lake city UT 84120
• Manufacturer (Section G): STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY; 4870 west 2100 south; salt lake city UT 84120
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 15886476
• Report Number: 3012931345-2022-00215
• Device Sequence Number: 5284166
• Product Code: DQO
• UDI-Device Identifier: 00815742002386
• UDI-Public: 00815742002386
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K113260
• 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): 01/06/2023

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: 11/15/2023
• Device Model Number: 90238
• Device Catalogue Number: 90238
• Device Lot Number: 0000091163
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/08/2022
• Supplement Date Received by Manufacturer: 12/14/2022
• Initial Report FDA Received Date: 11/30/2022
• Supplement Report FDA Received Date: 01/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2021
• 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: GUIDEWIRE (UNKNOWN)
• Patient Age: 40 YR
• Patient Sex: Unknown
• Patient Race: Asian