MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-03-29 for HEDGEHOG SBD-289-50 60252 manufactured by Boston Scientific Corporation.
[140339070]
Date of event was approximated to be (b)(6) 2019 as no event date was reported. 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. Visual inspection of the returned device found that the brush had broken off where the brush attaches to the catheter and was not returned. This occurred as a result of a mechanical fracture. No other issue was noted. Based on the evaluation of the returned device, the damage is consistent with forceful application of the brush through a scope, likely as a result if an occluded scope channel. A labeling review was performed and from the information available, this device was used in a manner inconsistent per the directions for use (dfu) / label. The directions for use (dfu) states that "endoscope channels may be damaged if brushes are forced through when channels are occluded or if resistance is met during brush passage. " therefore, the most probable cause for this event is failure to follow instructions, which indicates that the problem is traced to the user not following the manufacturer's instructions. A manufacturing batch record review was unable to be performed as the lot number is unknown. However, a ship history review was performed to identify the most probable lots, and a dhr history review on the most probable lots did not identify any deviations within manufacturing/service processes that could have contributed to the event.
Patient Sequence No: 1, Text Type: N, H10
[140339071]
A hedgehog double-end brush was returned to boston scientific and investigated on (b)(6) 019. There is no further information regarding this event. This event has been deemed reportable based on the investigation results; brush break.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2019-01532 |
| MDR Report Key | 8465319 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-03-29 |
| Date of Report | 2019-03-29 |
| Date of Event | 2019-01-01 |
| Date Mfgr Received | 2019-03-05 |
| Date Added to Maude | 2019-03-29 |
| 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 | 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 | 2019-03-29 |
| Returned To Mfg | 2019-01-30 |
| Model Number | SBD-289-50 |
| Catalog Number | 60252 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-03-29 |