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

Catalog Number	90238
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.Visual examination of the returned device revealed that the microcatheter shaft was found to be separated at approximately 2.0 cm distal to the strain relief.The microcatheter proximal shaft outer layer was fully cut but inner braiding were partially cut.Some braidings were cut and few were still intact.The microcatheter appeared to be cut with a sharp object.No other anomalies were observed with the device.Functional testing could not be performed due to the damaged condition of the returned device.It is possible that the microcatheter may have been damaged due to interaction with another device during use.However, based on the information currently available a definitive cause of the observed microcatheter shaft break could not be determined; therefore, an assignable cause of undeterminable was assigned.
Event or Problem Description
Analysis of the returned device noted that the microcatheter shaft was broken.No consequences to the patient were reported.

• Brand Name: TREVO PRO 18RO MICROCATHETER
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY; 4870 west 2100 south; salt lake city UT 84120
• MDR Report Key: 8352625
• Report Number: 3012931345-2019-00019
• Device Sequence Number: 19341675
• Product Code: DQO
• UDI-Device Identifier: 00815742002386
• UDI-Public: 00815742002386
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• 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
• Report Date (Section B): 02/19/2019

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: 01/31/2020
• Device Catalogue Number: 90238
• Device Lot Number: 0000004396
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2019
• Initial Report FDA Received Date: 02/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1