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 2020-03-19 for SENSATION SHORT THROW M00562672 6267-20 manufactured by Boston Scientific Corporation.
[188846117]
The exact date of the event is unknown. The provided event date of (b)(6) 2020 was chosen as a best estimate based on the date that the manufacturer became aware of the event. The complainant was unable to provide the lot number of the suspect device. Therefore, the manufacture and expiration dates are unknown. (b)(4). According to the complainant, the suspect device has been disposed and is not available for return. If any further relevant information is received, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[188846118]
It was reported to boston scientific corporation that a sensation medium oval flexible snare was used during a colonoscopy procedure performed on an unknown date. According to the complainant, during the procedure, the heat was not working properly as if cautery was not effective. They checked all machine settings and even swapped it out to make sure it was working but it felt like there was less heat energy produced than normal. Reportedly, the active cord was properly attached to the snare and no issues were noted with the handle and cautery pin. The procedure was completed with another sensation snare. The patient was fine at the conclusion of the procedure however, there was bleeding in the colon area and they used clips to resolve the bleeding but the patient was sent for hospitalization to be monitored. The patient's current condition post procedure was reported to be good.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2020-01235 |
| MDR Report Key | 9857070 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-19 |
| Date of Event | 2020-02-01 |
| Date Mfgr Received | 2020-02-26 |
| Date Added to Maude | 2020-03-19 |
| 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 | CAROLE MORLEY |
| Manufacturer Street | 300 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086834015 |
| Manufacturer G1 | BOSTON SCIENTIFIC DE COSTA RICA S.R.L. |
| Manufacturer Street | 256 CALLE PRIMERA PROPARK, COYOL |
| Manufacturer City | ALAJUELA |
| Manufacturer Country | CS |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SENSATION SHORT THROW |
| Generic Name | SNARE, FLEXIBLE |
| Product Code | FDI |
| Date Received | 2020-03-19 |
| Model Number | M00562672 |
| Catalog Number | 6267-20 |
| 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 | 300 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2020-03-19 |