MAUDE Adverse Event Report: ARGON MEDICAL DEVICES ATRIEVE VASCULAR SNARE KIT

Model Number 382007045

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/01/2020

Event Type  malfunction  

Manufacturer Narrative

The device is indicated as unavailable for evaluation.Without the sample or any visual evidence to review, the complaint cannot be confirmed.If additional information is received in the future, a follow-up report will be provided.

Event Description

During the surgical procedure snare caught on graft and broke off fragment remains in soft tissues out of blood flow isolated by vascular graft.

• Brand Name: ATRIEVE VASCULAR SNARE KIT
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX
• Manufacturer Contact: gina liu ; 1445 flat creek rd, athens, tx 75751
• MDR Report Key: 10477215
• MDR Text Key: 206500586
• Report Number: 1625425-2020-00495
• Device Sequence Number: 1
• Product Code: MMX
• UDI-Device Identifier: 20886333004014
• UDI-Public: 20886333004014
• Combination Product (y/n): N
• PMA/PMN Number: K021606
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 09/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 382007045
• Device Catalogue Number: 382007045
• Was Device Available for Evaluation?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other