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 2020-02-10 for SPEEDBAND SUPERVIEW SUPER 7 M00542253 4225-40 manufactured by Boston Scientific Corporation.
[178525441]
Patient's weight: (b)(6). (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 mdr will be filed.
Patient Sequence No: 1, Text Type: N, H10
[178525442]
It was reported to boston scientific corporation that two speedband superview super 7 devices were used in the esophagus during an esophagogastroduodenoscopy (egd) with variceal banding procedure performed on (b)(6) 2020. During the procedure, the speedband device was used in an attempt to stop the bleeding of the esophageal varices. The first two bands successfully deployed, and another two bands were attempted to be deployed, but the bands failed to deploy and blocked the ligator cap visualization. The scope was removed from the patient. A second speedband device was used; however, the same issue occurred. The physician then used a hemospray to stop the bleed. A pediatric esophagogastroduodenoscopy (egd) scope was also used to remove the blood. The patient was then intubated and was brought to the intensive care unit (icu). The physician assessed that the "bands lacerated the varices during the procure. " the patient has since been discharged from the icu, however the exact discharge date was not reported. The patient's current condition was reported to be stable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2020-00343 |
| MDR Report Key | 9687656 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-10 |
| Date of Report | 2020-02-10 |
| Date of Event | 2020-01-15 |
| Date Mfgr Received | 2020-01-16 |
| Device Manufacturer Date | 2019-11-08 |
| Date Added to Maude | 2020-02-10 |
| 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 CORPORATION |
| Manufacturer Street | 780 BROOKSIDE DRIVE |
| Manufacturer City | SPENCER IN 47460 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47460 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPEEDBAND SUPERVIEW SUPER 7 |
| Generic Name | LIGATOR, HEMORRHOIDAL |
| Product Code | FHN |
| Date Received | 2020-02-10 |
| Model Number | M00542253 |
| Catalog Number | 4225-40 |
| Lot Number | 0024739121 |
| 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. Required No Informationntervention | 2020-02-10 |