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 2019-05-02 for SPEEDBAND SUPERVIEW SUPER 7 M00542250 4225 manufactured by Boston Scientific Corporation.
[143889637]
(b)(4). Investigation result: only the ligator head was returned for analysis. A visual examination of the returned component found six bands present which were moved out of their position and some bands were caught under the other bands. It was noticed that the ligator head teeth were bent. The suture was intact and attached to the ligator head. The trip wire was cut with a sharp tool, the cut ends were inspected in magnified visual system. Based on the evaluation of the returned device, these failures are likely due to anatomical or procedural factors encountered during the procedure which limited the performance of the device. It is most likely that the ligator head teeth were damaged due to handling and manipulation of the device during procedure. Once the ligator head teeth are damaged, the suture can be detached from its position on the ligator head and this condition could have impacted the bands deployment activity, moving bands without being deployed, and contributing to the reported issues. Also the trip wire appears to had been cut with a sharp tool and this condition is not considered as an issue of the device. This failure is likely due to factors or conditions related to procedure during the use of the device that could have affected its performance and its intended purpose. Therefore, the most probable root cause is adverse event related to procedure. A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.
Patient Sequence No: 1, Text Type: N, H10
[143889638]
It was reported to boston scientific corporation that a speedband superview super 7 device was in the esophagus during an endoscopic variceal ligation (evl) procedure performed on (b)(6) 2019. According to the complainant, during the procedure, the bands were twisted. The procedure was completed with another speedband superview super 7 device. Additionally, it was noted that there was no difficulty when setting up the device. There were no patient complications reported as a result of this event. The patient condition at the conclusion of the procedure was reported to be stable. Investigation results showed that the bands failed to deploy and the ligator head teeth were damaged; this is now an mdr reportable event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2019-02335 |
| MDR Report Key | 8574649 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-05-02 |
| Date of Report | 2019-05-02 |
| Date of Event | 2019-03-08 |
| Date Mfgr Received | 2019-04-10 |
| Device Manufacturer Date | 2018-12-06 |
| Date Added to Maude | 2019-05-02 |
| 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 | MND |
| Date Received | 2019-05-02 |
| Returned To Mfg | 2019-03-22 |
| Model Number | M00542250 |
| Catalog Number | 4225 |
| Lot Number | 0023027452 |
| 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 | 2019-05-02 |