MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-27 for ROCKET R57422 manufactured by Rocket Medical Plc.
[78458346]
Patient Sequence No: 1, Text Type: N, H10
[78458347]
The 1st catheter md inserted catheter into the patient and the balloon would not inflate. The 2nd catheter md inflated balloon prior to insertion and inflated fine. Md inserted catheter into the patient and was not able to inflate the balloon once inserted. Md pulled catheter out and attempted to inflate the balloon and it would not inflate. The manufacturer is contacting their quality control department to investigate and have requested to send back the inventory and defective product.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6669245 |
| MDR Report Key | 6669245 |
| Date Received | 2017-06-27 |
| Date of Report | 2017-06-22 |
| Date of Event | 2017-06-20 |
| Report Date | 2017-06-22 |
| Date Reported to FDA | 2017-06-22 |
| Date Reported to Mfgr | 2017-06-22 |
| Date Added to Maude | 2017-06-27 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ROCKET |
| Generic Name | SONOHYSTOGRAM CATHETER |
| Product Code | HFF |
| Date Received | 2017-06-27 |
| Model Number | R57422 |
| Catalog Number | R57422 |
| Lot Number | 468380 |
| ID Number | 468149 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCKET MEDICAL PLC |
| Manufacturer Address | 150 RECREATION PARK DRIVE UNIT 1 HINGHAM MA 02043 US 02043 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-27 |