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 2020-02-12 for CAPTIVATOR EMR M00561610 50661 manufactured by Boston Scientific Corporation.
[188648962]
(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
[188648963]
It was reported to boston scientific corporation that a captivator endoscopic mucosal resection device was used in the esophagus during an esophagogastroduodenoscopy (egd) with endoscopic mucosal resection procedure performed on (b)(6) 2020. According to the complainant, during the procedure, it was noted that the suture broke in the working channel of the scope. Reportedly, the bands fell off the device inside of the patient. Two of the bands were retrieved from the back of the throat using forceps, and three bands migrated into the stomach. The sixth band could not be located so a bronchoscope was used to check the lungs. The bronchoscopy confirmed that the sixth band did not migrate to the patient's lungs. The procedure was completed with a different device. There was no serious injury nor adverse patient effects as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2020-00406 |
| MDR Report Key | 9699203 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-12 |
| Date of Report | 2020-02-12 |
| Date of Event | 2020-01-22 |
| Date Mfgr Received | 2020-01-23 |
| Device Manufacturer Date | 2019-08-25 |
| Date Added to Maude | 2020-02-12 |
| 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 | CAPTIVATOR EMR |
| Generic Name | ENDOSCOPE AND/OR ACCESSORIES |
| Product Code | FDI |
| Date Received | 2020-02-12 |
| Model Number | M00561610 |
| Catalog Number | 50661 |
| Lot Number | 0024546281 |
| 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 | 2020-02-12 |