MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-05 for ANGIOJET SOLENT DISTA 45030 manufactured by Boston Scientific Corporation.
[182210612]
Lot number: either 22987931 or 23122126. Device evaluated by mfr. : returned product consisted of a solent dista thrombectomy. The pump, effluent/supply line, shaft, tip, piston, and spike line were microscopically and visually inspected. Inspection of the device presented no damage or irregularities to the device, but the attached waste bag was new/not used as there was no fluid inside and it was still folded up. Functional testing was performed by placing the device in the angiojet console. The complaint device failed to prime and the 'check catheter for kinks' error was displayed on the console, meaning that the device over-pressured. The device was removed from the console and the shaft was inspected but there was no reason that would have caused an over-pressure alarm. The tip was cut, and the jets were microscopically inspected, and it showed that there was a jet hole that was plugged, causing the over pressure as the flow was being restricted. Further analysis revealed the obstructed jet hole was plugged with gold, which the jet body material is made of. Inspection of the remainder of the device revealed no damage or other irregularities.
Patient Sequence No: 1, Text Type: N, H10
[182210613]
Reportable based on the device analysis on 12feb2020. It was reported that catheter failure to prime occurred. An angiojet solent dista catheter was selected for a thrombectomy procedure. However, during preparation, it was noted that the device would not prime. The procedure was completed with another of the same device. No patient complicaions were reported. However, returned device analysis revealed a plugged jet hole.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-02577 |
| MDR Report Key | 9793038 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-05 |
| Date of Report | 2020-03-05 |
| Date of Event | 2020-01-13 |
| Date Mfgr Received | 2020-02-12 |
| Device Manufacturer Date | 2019-07-17 |
| Date Added to Maude | 2020-03-05 |
| 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 DISTA |
| Generic Name | CATHETER, EMBOLECTOMY |
| Product Code | DXE |
| Date Received | 2020-03-05 |
| Returned To Mfg | 2020-01-22 |
| Model Number | 45030 |
| Catalog Number | 45030 |
| 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 | 2020-03-05 |