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 2019-05-22 for RESOLUTION 360 CLIP M00521231 54773 manufactured by Boston Scientific Corporation.
[145850989]
Patient's exact age is unknown; however, it was reported that the patient was over the age of 18. Date of event was approximated to (b)(6) 2019 as event date is unknown. The complainant was unable to report the device lot number; therefore, the manufacture date and expiration date are unknown. (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 mdr will be filed.
Patient Sequence No: 1, Text Type: N, H10
[145850990]
It was reported to boston scientific corporation that a resolution 360 clip was used during a colonoscopy procedure performed on an unknown date. According to the complainant, during the procedure, the clip was attempted to be deployed but failed to separate from the catheter. The procedure was completed with another resolution clip 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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2019-02613 |
| MDR Report Key | 8633700 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-05-22 |
| Date of Report | 2019-05-22 |
| Date of Event | 2019-04-01 |
| Date Mfgr Received | 2019-04-30 |
| Date Added to Maude | 2019-05-22 |
| 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 | FREUDENBERG MEDICAL MIS (FM MIS) |
| Manufacturer Street | NORTH PORT INDUSTRIAL PARK 2301 CENTENNIAL BOULEVARD, |
| Manufacturer City | JEFFERSONVILLE IN 47130 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47130 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RESOLUTION 360 CLIP |
| Generic Name | HEMOSTATIC METAL CLIP FOR THE GI TRACT |
| Product Code | PKL |
| Date Received | 2019-05-22 |
| Model Number | M00521231 |
| Catalog Number | 54773 |
| 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 | 2019-05-22 |