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 2019-01-28 for HEDGEHOG SBD-289-50 60252 manufactured by Boston Scientific Corporation.
[134309535]
The complainant was unable to provide the suspect device lot number; therefore, the device manufacture date is unknown. This is a non-sterile device with no expiration date. (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
[134309536]
It was reported to boston scientific corporation that a hedgehog dual-end brush was used on (b)(6) 2019. According to the complainant, during cleaning, the brush was advanced down the scope. When it was being removed, the brush head broke off the catheter and fell off into the working channel of the scope. Another brush was used to push the detached brush head out of the scope. There were no patient complications reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2019-00275 |
| MDR Report Key | 8281848 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-01-28 |
| Date of Report | 2019-03-26 |
| Date of Event | 2019-01-04 |
| Date Mfgr Received | 2019-03-05 |
| Date Added to Maude | 2019-01-28 |
| 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 017521242 |
| Manufacturer Country | US |
| Manufacturer Postal | 017521242 |
| Manufacturer Phone | 5086834015 |
| Manufacturer G1 | SUZHOU TEMEIRUI MEDICAL PRODUCTS CO., LTD |
| Manufacturer Street | NO 699 PINAN ROAD PUZHAUNG LINHU TOWN, |
| Manufacturer City | WUZHONG DISTRICT, SUZHOU 21505 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 21505 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEDGEHOG |
| Generic Name | ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE |
| Product Code | MNL |
| Date Received | 2019-01-28 |
| Returned To Mfg | 2019-01-30 |
| Model Number | SBD-289-50 |
| Catalog Number | 60252 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | 100 BOSTON SCIENTIFIC WAY , MARLBOROUGH MA 017521242 US 017521242 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-28 |