MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-06 for MERIT MINI ACCESS KIT 00884450088838 MAK-NV-016/A manufactured by Merit Medical Systems.
[182455696]
The suspect device is not expected to return for evaluation. A follow up will be submitted when the evaluation is complete.
Patient Sequence No: 1, Text Type: N, H10
[182455697]
The account alleges that during a percutaneous nephrostomy tube placement procedure on an elderly female patient, a micropuncture access guidewire tip detached. The physician was attempting non-vascular access with eco/fluoroscopic guidance at the lower calyx of the kidney. During wire manipulations through an access needle, 4cm of the distal 0. 018 guidewire detached. The detached fragment of the non-vascular access wire remains within the patient's kidney. A post-procedural computed tomography [ct] scan was performed. Considering the health conditions of the patient and the existing comorbidities, the medical staff decided not to attempt to retrieve the foreign body fragment from the patient. The patient tolerated the procedure well with no additional consequences to report.
Patient Sequence No: 1, Text Type: D, B5
[188414336]
The suspect device was not returned for evaluation. Photographs of the used device were reviewed. The complaint was confirmed. The root cause could not be determined. A search of the complaint database was performed and no similar complaints for this lot number were found. The device history record was reviewed and no exception documents were found.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3011642792-2020-00004 |
| MDR Report Key | 9799391 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-06 |
| Date of Report | 2020-02-04 |
| Date of Event | 2020-01-22 |
| Date Mfgr Received | 2020-03-10 |
| Device Manufacturer Date | 2019-06-11 |
| Date Added to Maude | 2020-03-06 |
| 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 | MR. DAVID LOCKRIDGE |
| Manufacturer Street | 1600 MERIT PARKWAY |
| Manufacturer City | SOUTH JORDAN, UT |
| Manufacturer Country | US |
| Manufacturer Phone | 2084551 |
| Manufacturer G1 | MERIT MEDICAL SYSTEMS |
| Manufacturer Street | 8830 SIEMPRE VIVA RD #100 |
| Manufacturer City | SAN DIEGO,, CA |
| Manufacturer Country | US |
| 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 | GCB |
| Date Received | 2020-03-06 |
| Model Number | 00884450088838 |
| Catalog Number | MAK-NV-016/A |
| Lot Number | I1570906 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MERIT MEDICAL SYSTEMS |
| Manufacturer Address | 8830 SIEMPRE VIVA RD #100 SAN DIEGO,, CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-06 |