MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2017-05-19 for ATRIEVE VASCULAR SNARE 382006020 manufactured by Argon Medical Devices Inc..
[75546974]
There were no samples or images returned for review; however, a lot number was provided. A review of the device history records and inspection records was conducted and no similar concerns were found. Without the sample to review, a definite root cause and corrective action cannot be established. If the sample is returned at a future date, the complaint will be reopened for further evaluation. The complaint was reported to argon through another device manufacturer (spectranetics corporation). Per the email correspondence, "one of our spectranetics corporation sales reps was at a lead management case where an ae occurred and an argon medical device may have been involved. " a part number and lot number was provided, but spectranetics is "not sure if this is the exact device, model, or lot #. " the reported customer has not responded to any of the requests from argon. Based on the event description provided, it appears that the atrieve vascular snare was being used to remove leads that were attached to the heart. Per the atrieve instructions for use provided with this product, one of the warnings states, "this device is not intended for removal of implanted pacing leads. "
Patient Sequence No: 1, Text Type: N, H10
[75546975]
Initial narrative: (b)(6) woman post complicated extraction of co-radial atrial and ventricular leads including need for femoral lead extraction. Postoperative day 1 noted to have hypotension and found to have severe tricuspid regurgitation secondary to avulsion of the tricuspidvalve. She was sent for valve replacement for tr. In further conversation with the sales rep, it was reported that the physician thought that femoral snares were suspect in contributing to the tricuspid injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1625425-2017-00075 |
| MDR Report Key | 6578246 |
| Report Source | OTHER |
| Date Received | 2017-05-19 |
| Date of Report | 2017-05-19 |
| Date of Event | 2017-04-12 |
| Date Mfgr Received | 2017-04-27 |
| Device Manufacturer Date | 2016-09-08 |
| Date Added to Maude | 2017-05-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. GAIL SMITH |
| Manufacturer Street | 1445 FLAT CREEK ROAD |
| Manufacturer City | ATHENS TX 75751 |
| Manufacturer Country | US |
| Manufacturer Postal | 75751 |
| Manufacturer Phone | 2144368995 |
| Manufacturer G1 | ARGON MEDICAL DEVICES INC. |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ATRIEVE VASCULAR SNARE |
| Generic Name | VASCULAR SNARE |
| Product Code | MMX |
| Date Received | 2017-05-19 |
| Catalog Number | 382006020 |
| Lot Number | 11151864 |
| ID Number | NI |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARGON MEDICAL DEVICES INC. |
| Manufacturer Address | 1445 FLAT CREEK ROAD ATHENS TX 75751 US 75751 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-05-19 |