MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-02-26 for CLOSUREFAST MICRO INTRODUCER SHEATH SET 7FR/CH (2.3MM) X 7CM MIS-7F07 manufactured by Argon Medical Devices Inc..
[184448193]
The sample device was unavailable for evaluation. However, the issue of the hub separating from the dilator was investigated and captured in an internal corrective action, capa (b)(4). The investigation found that the root cause of the defect was non-optimized molding parameters (melt temperatures) and work instructions that were not specific enough regarding loading of the tubing on the mandrel. Plans for a full validation to establish the optimized upper, lower, and nominal process settings will follow.
Patient Sequence No: 1, Text Type: N, H10
[184448195]
Physician was attempting to use a micro introducer during procedure. The lumen was flushed prior to use. Ifu followed. Proper temperature was reached. It was reported that the sheath broke. Another micro introducer was attempted to be used and it also broke. The devices were pulled out and all pieces of the device are accounted for. Another introducer was used to complete the procedure. No additional treatment was required. There was no patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1625425-2020-00177 |
| MDR Report Key | 9753304 |
| Report Source | USER FACILITY |
| Date Received | 2020-02-26 |
| Date of Report | 2020-02-06 |
| Date of Event | 2020-02-05 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-02-06 |
| Date Added to Maude | 2020-02-26 |
| 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 SET |
| Product Code | DRE |
| Date Received | 2020-02-26 |
| Catalog Number | MIS-7F07 |
| Lot Number | 11284802 |
| 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 | 2020-02-26 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Manufacturer | MANUFACTURE / COMPOUNDER NAME |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-26 |