MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-10-29 for CAPIO SLIM M0068318250 831-825 manufactured by Boston Scientific Corporation.
[178763213]
(b)(4). The device has not been received for analysis. Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[178763254]
It was reported to boston scientific corporation that a capio slim device was used during a procedure performed on (b)(6) 2019. According to the complainant, while trying to use the device outside the patient, the device was loaded into the device. The dart was then detached from the device and flew off onto the floor. A second attempt was made but the same issue occurred. The dart was caught before it got lost on the floor. The device was not used in the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2019-05205 |
| MDR Report Key | 9252560 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-10-29 |
| Date of Report | 2019-10-29 |
| Date of Event | 2019-08-27 |
| Date Mfgr Received | 2019-10-03 |
| Device Manufacturer Date | 2019-03-19 |
| Date Added to Maude | 2019-10-29 |
| 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 | 2546 CALLE PRIMERA |
| Manufacturer City | ALAJUELA |
| Manufacturer Country | CS |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CAPIO SLIM |
| Generic Name | HOLDER, NEEDLE, GASTROENTEROLOGIC |
| Product Code | FHQ |
| Date Received | 2019-10-29 |
| Model Number | M0068318250 |
| Catalog Number | 831-825 |
| Lot Number | 0023510329 |
| 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 | 2019-10-29 |