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 2020-03-17 for ANGIOJET SOLENT OMNI 45031 manufactured by Boston Scientific Corporation.
[183877912]
It was reported that catheter break occurred. The 70% stenosed target lesion was located in the non-tortuous and severely calcified deep vein of the left limb. An angiojet solent omni was advanced for a thrombectomy procedure. During procedure, the catheter worked under thrombectomy mode for about 5 seconds however, a fracture near the connector of the y-valve on the golden catheter was noted. There was no visible damage on the catheter but catheter was leaking liquid and there was liquid in the pump. The procedure was completed with another of the same device. No patient complications were reported and the patient's status was stable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-03380 |
| MDR Report Key | 9843031 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-17 |
| Date of Event | 2020-02-20 |
| Date Mfgr Received | 2020-02-25 |
| Device Manufacturer Date | 2019-09-12 |
| Date Added to Maude | 2020-03-17 |
| 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 | 500 COMMANDER SHEA BOULEVARD |
| Manufacturer City | QUINCY MA 02171 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02171 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ANGIOJET SOLENT OMNI |
| Generic Name | CATHETER, EMBOLECTOMY |
| Product Code | DXE |
| Date Received | 2020-03-17 |
| Returned To Mfg | 2020-03-11 |
| Model Number | 45031 |
| Catalog Number | 45031 |
| Lot Number | 0024597975 |
| 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 | 2020-03-17 |