MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-19 for SAPPHIRE II PRO 7-10051-06 manufactured by Cardiovascular Systems Inc.
[184072048]
Dr. Stated the patient had a very calcified vessel that he attempted to cross with the balloon. The balloon crossed and was inflated. He indicated that the balloon did rupture after inflation and that it was difficult to remove from the body. It was noted post removal of the balloon that the single marker that is on the balloon was retained in the vessel. No harm was noted to patient. The marker came off the balloon when removing device from body. The balloon was still intact when removed, but marker remained in the body. Manufacturer response for balloon catheter, sapphire ii pro (per site reporter). Unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9853071 |
| MDR Report Key | 9853071 |
| Date Received | 2020-03-19 |
| Date of Report | 2020-02-05 |
| Date of Event | 2020-01-20 |
| Report Date | 2020-02-05 |
| Date Reported to FDA | 2020-02-05 |
| Date Reported to Mfgr | 2020-03-19 |
| Date Added to Maude | 2020-03-19 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | SAPPHIRE II PRO |
| Generic Name | CATHETER, PERIPHERAL, ATHERECTOMY |
| Product Code | MCW |
| Date Received | 2020-03-19 |
| Returned To Mfg | 2020-01-31 |
| Catalog Number | 7-10051-06 |
| Lot Number | 4271331809 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDIOVASCULAR SYSTEMS INC |
| Manufacturer Address | 1225 OLD HWY 8 NW NEW BRIGHTON MN 55112 US 55112 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-19 |