MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-02-06 for ONE STEP MARKED INTRO KIT W/SS WIRE & NDLE 4F X 65CM TVS2065MSN manufactured by Argon Medical Devices Inc..
[183135989]
A sample was not available for review; however, an image was provided for a similar complaint (b)(4). The image was examined and there was a segment of the introducer near the distal end that was partially collapsed as if it were melted. Therefore, this complaint is confirmed. Without an evaluation of the actual device, a root cause cannot be determined with confidence. However, based on the provided image, it is likely that the use of the laser resulted in the damage to the introducer in which the heat caused the introducer to melt and collapse. Since the alleged complaint was most likely due to an event within the user environment, no corrective action will be taken at this time.
Patient Sequence No: 1, Text Type: N, H10
[183135990]
In both cases when the laser fiber was removed, it was noted that approximately 9mm segment of the distal portion of the sheath was absent. We have also reported these two case to fda medwatch.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1625425-2020-00123 |
| MDR Report Key | 9679383 |
| Report Source | USER FACILITY |
| Date Received | 2020-02-06 |
| Date of Report | 2020-01-14 |
| Date of Event | 2019-12-12 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-01-14 |
| Date Added to Maude | 2020-02-06 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ONE STEP MARKED INTRO KIT W/SS WIRE & NDLE 4F X 65CM |
| Generic Name | INTRODUCER KIT |
| Product Code | DRE |
| Date Received | 2020-02-06 |
| Catalog Number | TVS2065MSN |
| Lot Number | 11254342 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARGON MEDICAL DEVICES INC. |
| Manufacturer Address | 1445 FLAT CREEK ROAD ATHENS TX 75751 US 75751 |
| Brand Name | ACETAMINOPHEN 500MG |
| Product Code | --- |
| Date Received | 2020-02-06 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Manufacturer | MANUFACTURE / COMPOUNDER NAME |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-06 |