MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-03-19 for PROGUIDE CHRONIC DIALYSIS CATHETER 00884450023426 DC21452419/A manufactured by Merit Medical Systems Inc..
[186548684]
The suspect device is expected to return for evaluation. A follow up will be submitted when the evaluation is complete.
Patient Sequence No: 1, Text Type: N, H10
[186548685]
The account alleges that during and attempted dialysis treatment procedure, the endcaps detached from the catheter. The patient had the dialysis catheter placed at the same facility on (b)(6) 2020. The patient's anatomy was extremely challenging during placement. During attempts to remove the end caps from the catheter on (b)(6) 2020 at the dialysis center, the caps became stuck. During additional removal attempts, the catheter hub detached from the catheter. The patient was doing fine and was sent to a local hospital for a new catheter exchange because the dialysis center was closing. The patient was an out-patient in radiology, the catheter was re-wired, and a new catheter was placed. No patient injury to report. Patient tolerated this procedure well. Dialysis was completed the next morning at the center without additional consequences to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1721504-2020-00013 |
| MDR Report Key | 9857536 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-03-19 |
| Date of Report | 2020-02-18 |
| Date of Event | 2020-01-31 |
| Date Mfgr Received | 2020-02-18 |
| Device Manufacturer Date | 2019-09-26 |
| Date Added to Maude | 2020-03-19 |
| 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 INC. |
| Manufacturer Street | 1600 MERIT PARKWAY |
| Manufacturer City | SOUTH JORDAN,, UT |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROGUIDE CHRONIC DIALYSIS CATHETER |
| Generic Name | CHRONIC DIALYSIS CATHETER |
| Product Code | MSD |
| Date Received | 2020-03-19 |
| Model Number | 00884450023426 |
| Catalog Number | DC21452419/A |
| Lot Number | H1671893 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MERIT MEDICAL SYSTEMS INC. |
| Manufacturer Address | 1600 MERIT PARKWAY SOUTH JORDAN,, UT US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-19 |