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 2020-03-09 for ANGIOJET SOLENT DISTA 45030 manufactured by Boston Scientific Corporation.
[182597666]
Device evaluated by mfr. : returned product consisted of a solent dista thrombectomy in two pieces. The pump, effluent/supply line, shaft, tip, piston, and spike line were microscopically and visually inspected. There was blood present in the device. Inspection of the device revealed that the shaft was detached 59cm distal of the strain relief. The shaft appeared to have been kinked/bent prior to separation. With the shaft separated, the hypotube would also be separated in the same location. When the hypotube is broken, the device will not prime and the console will continue to try and prime the catheter. This will cause the 'check saline supply' error to display on the console and the device not to prime.
Patient Sequence No: 1, Text Type: N, H10
[182597667]
Reportable based on device analysis completed on 21-feb-2020. It was reported that device displays error message. After two angiojet solent dista catheters were used but failed the priming process, another catheter was advanced for a thrombectomy procedure. After the catheter was successfully primed, the catheter was put over the unknown wire and was introduced into the patient. However, the catheter would not function and check saline supply error occurred. The physician ended up infusing the patient overnight with a non-bsc device and going to look at it again the next day. No patient complications were reported. However, device analysis revealed a hypotube and shaft detachment/separation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-02776 |
| MDR Report Key | 9805137 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-09 |
| Date of Report | 2020-03-09 |
| Date of Event | 2020-01-29 |
| Date Mfgr Received | 2020-02-21 |
| Device Manufacturer Date | 2019-01-15 |
| Date Added to Maude | 2020-03-09 |
| 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 | 2020-03-09 |
| Returned To Mfg | 2020-02-06 |
| Model Number | 45030 |
| Catalog Number | 45030 |
| Lot Number | 0023290759 |
| 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 | 2020-03-09 |