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 2019-05-31 for RESOLUTION CLIP CLIPPING DEVICE M00522612 2261 manufactured by Boston Scientific Corporation.
[146700698]
Patient's exact age is unknown; however, it was reported that the patient was over the age of 18. (b)(4). According to the complainant, the suspect device has been disposed and is not available for return. If any further relevant information is received, a supplemental mdr will be filed.
Patient Sequence No: 1, Text Type: N, H10
[146700699]
It was reported to boston scientific corporation that a resolution clip device was used during a colonoscopy procedure performed on (b)(6) 2019. According to the complainant, during the procedure, the clip was attempted to be deployed. Reportedly, the clip did not deploy properly. The procedure was completed with another resolution clip device. No patient complications have been reported as a result of this event. Attempts to obtain additional information regarding this event have been unsuccessful to date. Should additional relevant details become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2019-02778 |
| MDR Report Key | 8659821 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-05-31 |
| Date of Report | 2019-05-31 |
| Date of Event | 2019-05-07 |
| Date Mfgr Received | 2019-05-07 |
| Device Manufacturer Date | 2018-11-05 |
| Date Added to Maude | 2019-05-31 |
| 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 DE COSTA RICA S.R.L. |
| Manufacturer Street | 2546 CALLE PRIMERA PROPARK, COYOL |
| Manufacturer City | ALAJUELA |
| Manufacturer Country | CS |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RESOLUTION CLIP CLIPPING DEVICE |
| Generic Name | CLIP, HEMOSTATIC |
| Product Code | MCH |
| Date Received | 2019-05-31 |
| Model Number | M00522612 |
| Catalog Number | 2261 |
| Lot Number | 0022891768 |
| 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 | 2019-05-31 |