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 2020-03-13 for FLEXTOME CUTTING BALLOON 3822 manufactured by Boston Scientific Corporation.
[183328314]
Device evaluated by mfr: the device was returned for analysis. A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure. The returned device was attached to a boston scientific encore inflation unit. Positive pressure was applied when liquid was observed to be leaking from a balloon pinhole located at the proximal markerband. An examination of the balloon material and proximal markerband identified no issues which could potentially have contributed to this complaint. No issues were noted with the tip section of the device. A visual and microscopic examination found no issue with the markerbands. A visual and tactile examination found no issues or damage to the shaft or hypotube of the device. No other issues were identified during the product analysis.
Patient Sequence No: 1, Text Type: N, H10
[183328315]
Reportable based on device analysis completed on 29feb2020. It was reported that the balloon could not inflate. The more than 70% stenosed target lesion was located in the left anterior descending artery. A 10/3. 00 flextome cutting balloon was selected for use. During the procedure, it was noted that the balloon could not inflate. The balloon was removed from the patient without any intervention and the procedure was completed with a different device. No patient complications were reported and the patient was stable post procedure. However, device analysis revealed a balloon pinhole located at the proximal markerband.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-03175 |
| MDR Report Key | 9831145 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-03-13 |
| Date of Report | 2020-03-13 |
| Date of Event | 2020-01-04 |
| Date Mfgr Received | 2020-02-29 |
| Device Manufacturer Date | 2019-07-02 |
| Date Added to Maude | 2020-03-13 |
| 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 | FLEXTOME CUTTING BALLOON |
| Generic Name | CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS |
| Product Code | NWX |
| Date Received | 2020-03-13 |
| Returned To Mfg | 2020-01-29 |
| Model Number | 3822 |
| Catalog Number | 3822 |
| Lot Number | 0024045380 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2020-03-13 |