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 2020-03-23 for EQUALIZER 20280 manufactured by Boston Scientific Corporation.
[184461508]
(b)(6).
Patient Sequence No: 1, Text Type: N, H10
[184461509]
It was reported that balloon deflation failure occurred. The target lesion was located in severely tortuous aorta-iliac. During the procedure, an equalizer 33/7/2/100 balloon catheter was advanced for dilatation. After the stent graft was placed, touch-up was performed without a problem from the aorta to the leg from the left side femoral. Next, after dilation was performed, when touch-up was performed from the right side femoral with the use of the same balloon, negative pressure was applied, but deflation could not be performed. The 20cc syringe was changed to 10cc syringe in first inflation and was able to perform the deflation slowly for four to five minutes manually and saline contrast ratio was approximately 50:50. This was attempted three times using the same size, 33mm, and 27mm all had the same issue. Eventually, touch-up was performed using gores coda balloon and was able to deflate with no resistance felt. The cause was not confirmed since the blood vessel was relatively straight anatomically. Moreover, there should be no resistance felt since the sheath was for stent graft and the lumen was thick. The procedure was completed with another of same device. There were no patient complications nor injuries reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-03688 |
| MDR Report Key | 9865324 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-03-23 |
| Date of Report | 2020-03-23 |
| Date of Event | 2020-03-10 |
| Date Mfgr Received | 2020-03-10 |
| Device Manufacturer Date | 2019-10-07 |
| Date Added to Maude | 2020-03-23 |
| 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 CORPORATION |
| Manufacturer Street | MODEL FARM ROAD |
| Manufacturer City | CORK |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EQUALIZER |
| Generic Name | CATHETER, PERCUTANEOUS |
| Product Code | MJN |
| Date Received | 2020-03-23 |
| Model Number | 20280 |
| Catalog Number | 20280 |
| Lot Number | 0024552391 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 12 | 2020-03-23 |