MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-09-06 for MERIT MINI ACCESS KIT. K12-08274 manufactured by Merit Medical Systems Inc..
[156752095]
The suspect device has is not returning for evaluation. A follow up will be submitted when the evaluation is complete.
Patient Sequence No: 1, Text Type: N, H10
[156752096]
The account alleges that while attempting access for a mechanochemical ablation [moca] procedure, the micro access wire tip unraveled and detached within the patient's subcutaneous tissue. The physician was able to successfully remove the detached wire tip from the patient by hand. No patient injury to report.
Patient Sequence No: 1, Text Type: D, B5
[163049674]
The suspect device was returned for evaluation. The device was examined visually. The complaint is confirmed. The root cause could not be determined. A review of the device history record was performed and no exception documents were found. A review of the complaint database was performed and no similar complaints for this lot number were found.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1721504-2019-00071 |
| MDR Report Key | 8969810 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-09-06 |
| Date of Report | 2019-08-13 |
| Date of Event | 2019-08-13 |
| Date Mfgr Received | 2019-09-13 |
| Device Manufacturer Date | 2018-11-21 |
| Date Added to Maude | 2019-09-06 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. KATIE SWENSON CQE,CBA,CQPA. |
| Manufacturer Street | 1600 MERIT PARKWAY |
| Manufacturer City | SOUTH JORDAN UT 84095 |
| Manufacturer Country | US |
| Manufacturer Postal | 84095 |
| Manufacturer Phone | 8012531600 |
| Manufacturer G1 | MERIT MEDICAL SYSTEMS INC. |
| Manufacturer Street | 1600 MERIT PARKWAY |
| Manufacturer City | SOUTH JORDAN, UT 84095 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 84095 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MERIT MINI ACCESS KIT. |
| Generic Name | ACCESS KIT |
| Product Code | OEQ |
| Date Received | 2019-09-06 |
| Returned To Mfg | 2019-08-20 |
| Catalog Number | K12-08274 |
| Lot Number | H1474576 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MERIT MEDICAL SYSTEMS INC. |
| Manufacturer Address | 1600 MERIT PARKWAY SOUTH JORDAN, UT 84095 US 84095 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-09-06 |