MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2020-03-27 for 2CM PERIPHERAL CUTTING BALLOON 24630 manufactured by Boston Scientific Corporation.
[187708376]
It was reported that blades of the cutting balloon cut the patient during removal. The 99% stenosed target lesion was located in the moderately tortuous and moderately calcified left external iliac artery. A 6. 00mm/2. 0cm/90cm peripheral cutting balloon was selected for use. During the procedure, pre dilation was performed using a 3mm-20mm and 5mm-40mm after the guidewire was crossed and then this device was used. The balloon position was slightly shifted at 6atm for about 30 seconds on the first time, and the vessel was dilated three times at about 6atm to 8atm for about 30 seconds. Inflation and deflation were performed slowly, however the blade protruded from the sheath upon removal and bleeding was noted. As per physician, the blade cut the skin at the puncture sit which made the site expanded. The procedure was completed with a different device. There were no patient complications reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-03967 |
| MDR Report Key | 9888381 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date of Event | 2020-03-06 |
| Date Mfgr Received | 2020-03-06 |
| Device Manufacturer Date | 2019-09-23 |
| Date Added to Maude | 2020-03-27 |
| 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 | JAY JOHNSON |
| Manufacturer Street | TWO SCIMED PLACE |
| Manufacturer City | MAPLE GROVE MN 55311 |
| Manufacturer Country | US |
| Manufacturer Postal | 55311 |
| Manufacturer Phone | 7634942574 |
| Manufacturer G1 | BOSTON SCIENTIFIC IRELAND LIMITED |
| Manufacturer Street | BALLYBRIT BUSINESS PARK |
| Manufacturer City | GALWAY |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 2CM PERIPHERAL CUTTING BALLOON |
| Generic Name | CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA |
| Product Code | LIT |
| Date Received | 2020-03-27 |
| Returned To Mfg | 2020-03-23 |
| Model Number | 24630 |
| Catalog Number | 24630 |
| Lot Number | 0024476257 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | TWO SCIMED PLACE MAPLE GROVE MN 55311 US 55311 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-27 |