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 2020-03-20 for ANGIOJET ZELANTEDVT 45027 manufactured by Boston Scientific Corporation.
[184413907]
Device evaluated by mfr. : returned product consisted of a zelantedvt thrombectomy system. The pump number was reviewed in sap and confirmed to be from finished goods batch, which matches the reported batch number. 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. 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. The jet body was cut-off from the device. Additional testing was performed on the plugged jet hole. The eds identified that the source of the fm that was obstructing the jet hole was identified as stainless steel, which the jet body material is made of.
Patient Sequence No: 1, Text Type: N, H10
[184413908]
Reportable based on device analysis completed on (b)(6) 2020. It was reported that the catheter was unable to prime. An angiojet zelanted vt catheter was selected for a deep venous thrombosis procedure. The catheter would not prime properly and it did not entered the patient's body. The procedure was completed with another of the same device. No patient complications were reported. However, device analysis revealed a plugged jet hole.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-03641 |
| MDR Report Key | 9860641 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-20 |
| Date of Event | 2019-10-01 |
| Date Mfgr Received | 2020-03-06 |
| Device Manufacturer Date | 2019-06-19 |
| Date Added to Maude | 2020-03-20 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 ZELANTEDVT |
| Generic Name | CATHETER, EMBOLECTOMY |
| Product Code | KRA |
| Date Received | 2020-03-20 |
| Returned To Mfg | 2020-02-12 |
| Model Number | 45027 |
| Catalog Number | 45027 |
| Lot Number | 0024207805 |
| 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 | 2020-03-20 |