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 INNOVA VASCULAR 26928 manufactured by Boston Scientific Corporation.
[184305332]
It was reported that the stent inadvertently partially deployed. An 6 x 100 x 130 inova, non-bsc guidewire and non-bsc sheath were selected for a procedure. During preparation, the stent was partially deployed 5mm outside of the delivery catheter after it was removed from the packaging. The procedure was successfully completed with another innova stent. There were no patient complications and the stent was never introduced into the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-03601 |
| MDR Report Key | 9860913 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-20 |
| Date of Event | 2020-03-04 |
| Date Mfgr Received | 2020-03-04 |
| Device Manufacturer Date | 2016-05-03 |
| 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 | PHYSICIAN ASSISTANT |
| 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 SCIMED, INC |
| 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 | INNOVA VASCULAR |
| Generic Name | STENT, SUPERFICIAL FEMORAL ARTERY |
| Product Code | NIP |
| Date Received | 2020-03-20 |
| Model Number | 26928 |
| Catalog Number | 26928 |
| Lot Number | 0024888855 |
| 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 | 0 | 2020-03-20 |