MAUDE Adverse Event Report: MERIT MEDICAL IRELAND LTD EN SNARE; EN SNARE ENDOVASCULAR SNARE SYSTEM

Catalog Number EN2006015

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

Patient Problem Foreign Body In Patient (2687)

Event Date 06/29/2018

Event Type  Injury  

Manufacturer Narrative

The suspect device has returned for evaluation.A follow up will be submitted when the evaluation is complete.

Event Description

The account alleges that during a percutaneous transluminal angioplasty procedure, the marker band from a snare delivery catheter detached within a patient.The patient was placed in the supine position on the exam table and the vascular access site was prepped and draped in a sterile fashion.A local anesthetic was administered to numb the skin for comfort and access sheath placement.While manipulating a vascular snare delivery catheter to capture an interventional wire within the patient's lower periphery, the marker band on the snare delivery catheter detached.The physician then used the vascular snare device to successfully retrieve the marker band from the patient's vasculature leading to only a moderate delay in procedure.

Manufacturer Narrative

The suspect device was returned for evaluation.The device was examined visually.The complaint is confirmed.The root cause is unknown.A review of the device history record was performed and no exception documents were found.A review of the complaint database was performed and no similar complaints for this lot number were found.

• Brand Name: EN SNARE
• Type of Device: EN SNARE ENDOVASCULAR SNARE SYSTEM
• Manufacturer (Section D): MERIT MEDICAL IRELAND LTD; parkmore business park west; ballybrit; galway, ; EI
• Manufacturer (Section G): MERIT MEDICAL IRELAND LTD; parkmore business park west; ballybrit; galway, ; EI
• Manufacturer Contact: katie swenson cqe,cba,cqpa. ; 1600 merit parkway; south jordan, UT 84095 ; 8012531600
• MDR Report Key: 7685689
• MDR Text Key: 113907537
• Report Number: 9616662-2018-00013
• Device Sequence Number: 1
• Product Code: MMX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K092343
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Catalogue Number: EN2006015
• Device Lot Number: K951290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/04/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/25/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention