MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY TREVO XP PROVUE 4MM X 30MM; CATHETER, THROMBUS RETRIEVER

Model Number	90185
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This 1 of 2 reports.Although the dhr could not be reviewed because the lot number remains unknown, 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 the patient anatomy was very tortuous and 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, a cause of 'undeterminable' shall be assigned to the as reported events.Device is not available to manufacturer.
Event or Problem Description
Analysis of the catheter returned concluded that the metal parts that seem to be part of the product comes out when it was bent was not from the catheter.Based on the analysis and investigation, the metal parts might have been the parts of a retriever (subject device) that broke during the procedure with an awareness date of (b)(6) 2020.No clinical consequences were reported to the patient due to this event.

• Brand Name: TREVO XP PROVUE 4MM X 30MM
• Common Device Name: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY; 4870 west 2100 south; salt lake city UT 84120
• MDR Report Key: 10489049
• Report Number: 3012931345-2020-00127
• Device Sequence Number: 11363684
• Product Code: NRY
• UDI-Device Identifier: 00815742001853
• UDI-Public: 00815742001853
• Combination Product (Y/N): N
• Initial Reporter Country: JP
• PMA/510(K) Number: K150616
• 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): 09/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 90185
• Device Catalogue Number: 90185
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/11/2020
• Initial Report FDA Received Date: 09/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AXS CATALYST 6 MICROCATHETER (STRYKER); FLOWGATE BALLOON CATHETER (STRYKER); HEADWAY MICROCATHETER (MICROVENTION)