MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-02-21 for CLOSUREFAST MICRO INTRODUCER SHEATH SET 7FR/CH (2.3MM) X 7CM MIS-7F07 manufactured by Argon Medical Devices Inc..
[184446657]
The root cause has been identified as non-optimized molding parameters (melt temperatures) and work instructions that were not specific enough regarding loading of the tubing on the mandrel. A capa (reference capa (b)(4)) has been initiated to address the manufacturing error.
Patient Sequence No: 1, Text Type: N, H10
[184446658]
Physician was attempting to use a micro introducer along with a rfg3 during procedure to treat the great saphenous vein (gsv). The lumen was flushed prior to use. Ifu was followed. Proper temperature was reached. A guide wire was used for the insertion of the catheter. It was reported that the blue dilator broke off the hub of the sheath, it was a clean break off the combined blue and orange hub. Since the break was clean, physician pulled blue introducer out that broke off the hub and re-opened another micro kit to complete the procedure. There was no patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1625425-2020-00174 |
| MDR Report Key | 9739969 |
| Report Source | USER FACILITY |
| Date Received | 2020-02-21 |
| Date of Report | 2020-02-03 |
| Date of Event | 2020-01-29 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-02-03 |
| Date Added to Maude | 2020-02-21 |
| 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 | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLOSUREFAST MICRO INTRODUCER SHEATH SET 7FR/CH (2.3MM) X 7CM |
| Generic Name | MICRO INTRODUCER SHEATH |
| Product Code | DRE |
| Date Received | 2020-02-21 |
| Catalog Number | MIS-7F07 |
| Lot Number | UNK |
| 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 | 2020-02-21 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Manufacturer | MANUFACTURE / COMPOUNDER NAME |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-21 |