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

Catalog Number EN2006010

Device Problems Detachment Of Device Component (1104); Material Separation (1562); Component Missing (2306)

Patient Problems Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)

Event Date 04/21/2015

Event Type  malfunction  

Event Description

The user reported that, during a percutaneous transluminal angioplasty, the marker band on the catheter became detached.While the catheter was being pulled through a lesion resistance was felt.The catheter was removed and the marker band was missing.The marker band was found in the location where the stent was planned.The stent was deployed over the lesion and marker band.No harm or injury to the patient was reported.

Manufacturer Narrative

One used device was returned for evaluation.The evaluation is in-process.A follow up report will be submitted when the evaluation has been completed.

Manufacturer Narrative

Device evaluation: one device was returned for evaluation.The device was visually inspected and the marker band was not attached to the catheter.The complaint was confirmed.The catheter showed evidence that the marker band had been attached.The marker band was not returned with the catheter.Without the entire device to evaluate, the root cause of the failure cannot be determined.The device history record was reviewed and no exception documents were found.A corrective action is in process to address this failure mode.

• Brand Name: EN SNARE®
• Type of Device: EN SNARE ENDOVASCULAR SNARE SYSTEM
• Manufacturer (Section D): MERIT MEDICAL IRELAND LTD.; parkmore industrial estate; galway, ; EI
• Manufacturer (Section G): FIELD ASSURANCE; 1600 west merit parkway; south jordan UT 84095
• Manufacturer Contact: jerry mcphie ; 1600 west merit parkway; south jordan 84095 ; 8012084491
• MDR Report Key: 4899007
• MDR Text Key: 6019524
• Report Number: 9616662-2015-00007
• 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: Foreign,User Facility,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/30/2017
• Device Catalogue Number: EN2006010
• Device Lot Number: K658737
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2014
• 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