MAUDE Adverse Event Report: CONCENTRIC MEDICAL TREVO PROVUE; CATHETER, THROMBUS RETRIEVER

Catalog Number	90184
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.The trevo provue retriever device was returned with an insertion tool.Visual examination of the returned device revealed that the retriever shaft coil was found to be kinked.The trevo provue distal platinum coil was protruding through the insertion tool distal end.The trevo provue distal platinum coil was kinked just proximal to the distal tip.The insertion tool was slightly bent at approximately 10.0cm from its distal end.The trevo provue struts were found to be bent on distal section.During functional testing, the trevo provue was advanced through the returned insertion tool (friction was encountered while advancing) and through the demo mc-18 catheter.There was friction encountered while advancing the trevo provue retriever.The anomalies found on the trevo provue are known to adversely affect the functional performance.The complaint that the trevo was kinked on its distal tip was confirmed due to the anomalies found on the trevo provue retriever distal platinum coil.Therefore, an assignable cause of procedural factors is assigned to the as reported and as analyzed codes.
Event or Problem Description
Analysis of the returned retriever (subject device) revealed that the platinum wire had broken.There were no clinical consequences to the patient.

• Brand Name: TREVO PROVUE
• Common Device Name: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): CONCENTRIC MEDICAL; 301 east evelyn; mountain view CA 94041
• MDR Report Key: 7981012
• Report Number: 0002954917-2018-00081
• Device Sequence Number: 1526077
• Product Code: NRY
• UDI-Device Identifier: 00815742001846
• UDI-Public: 00815742001846
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K133464
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/18/2018

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: 01/28/2019
• Device Catalogue Number: 90184
• Device Lot Number: 61683
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2018
• Initial Report FDA Received Date: 10/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 75