MAUDE Adverse Event Report: COOK INC CLOVERSNARE¿ 4-LOOP VASCULAR RETRIEVER; MMX DEVICE, PERCUTANEOUS RETRIEVAL

Catalog Number VRS-6.0-90

Device Problems Fracture (1260); Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/08/2016

Event Type  malfunction  

Manufacturer Narrative

This mdr is being filed after the associated complaint was reviewed under remediation protocol cap008, complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.

Event Description

It was reported that after snaring the filter, while putting tension on the proximal clover snare catheter, the catheter fractured and came apart.A separation occurred below the hub.The filter was successfully retrieved without harm to the patient.

• Brand Name: CLOVERSNARE¿ 4-LOOP VASCULAR RETRIEVER
• Type of Device: MMX DEVICE, PERCUTANEOUS RETRIEVAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 7480623
• MDR Text Key: 107503609
• Report Number: 1820334-2018-01369
• Device Sequence Number: 1
• Product Code: MMX
• UDI-Device Identifier: 10827002530086
• UDI-Public: (01)10827002530086(17)190408(10)6878157
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: VRS-6.0-90
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1