MAUDE Adverse Event Report: EXIMO MEDICAL LTD. CATHETER EXIMO ATHERECTOMY PERIPHERAL ATHERECTOMY CATHETER,

Catalog Number EXM-4003-0000

Device Problem Material Perforation (2205)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/28/2020

Event Type  malfunction  

Manufacturer Narrative

It was reported that the device is not available to be returned to the manufacturer for evaluation. The results of the investigation will be sent via a follow up medwatch. Reference (b)(4).

Event Description

An angiodynamics executive district sales manager reported an issue with a 2. 0mm eximo atherectomy catheter. The device was used in a 6f cook sheath and sheared off a long and large section of the sheath. This was noted after the device was removed between treatments. The procedure was completed with a 1. 5mm device and the patient did not experience any adverse effects, harm, or require medical intervention as a result of this incident. It was indicated the reported device is available for return to the manufacturer for a device evaluation.

• Brand Name: CATHETER EXIMO ATHERECTOMY
• Type of Device: PERIPHERAL ATHERECTOMY CATHETER,
• Manufacturer (Section D): EXIMO MEDICAL LTD.; 3 pekeris street; glens falls, ny 12801, rehovot 76702 03; IS 7670203
• Manufacturer (Section G): EXIMO LTD.; 3 pekeris street; building 2, suite 270; science park, rehovot 76702 03; IS 7670203
• Manufacturer Contact: dr. yossi muncher ; 3 pekeris street; building 2, suite 270; science park, rehovot 76702-03 ; IS 7670203
• MDR Report Key: 11182954
• MDR Text Key: 256116439
• Report Number: 1319211-2021-10002
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 02/22/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 01/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: EXM-4003-0000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial