MAUDE Adverse Event Report: ARGON MEDICAL DEVICES INC. TRIPLE-LOOP SNARE RETRIEVAL KIT

Catalog Number 380911330

Device Problems Break (1069); Migration or Expulsion of Device (1395)

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

Event Date 03/06/2020

Event Type  malfunction  

Manufacturer Narrative

The sample device is indicated as unavailable for evaluation.Without such evidence, a root cause cannot be determined.If additional information is received, a follow-up report will be provided.

Event Description

During retrieval, all snare loops broke off the wire and floated free in the ivc.

• Brand Name: TRIPLE-LOOP SNARE RETRIEVAL KIT
• Type of Device: RETRIEVAL KIT
• Manufacturer (Section D): ARGON MEDICAL DEVICES INC.; 1445 flat creek road; athens TX 75751
• Manufacturer (Section G): ARGON MEDICAL DEVICES INC.
• Manufacturer Contact: gail smith ; 1445 flat creek road; athens, TX 75751 ; 2144368995
• MDR Report Key: 9914089
• MDR Text Key: 187036581
• Report Number: 1625425-2020-00262
• Device Sequence Number: 1
• Product Code: MMX
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K191758
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/01/2005,03/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 380911330
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 03/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other