MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2020-03-31 for INTERLOCK-35 83786 manufactured by Boston Scientific Corporation.
[185942880]
Device evaluated by mfr: the device was returned for analysis. A delivery wire and the piece of interlocking arm from the main coil was returned. Visual inspection of the interlocking arm showed it was detached from the rest of the mail coil, in addition the main coil was not returned. No damages were found with the delivery wire. Microscopic inspection of the delivery wire showed that the proximal end has a smooth surface. The interlocking arm was in good condition. Dimensional inspection of the delivery wire weld outer diameter (od), wire arm od, and wire zap tip were performed and were within specifications.
Patient Sequence No: 1, Text Type: N, H10
[185942881]
Reportable based on device analysis completed on 17mar2020. It was reported that the coil detached prematurely inside the coil sheath. A 10mm x 40cm interlock-35 coil was selected for an embolization procedure of the pelvic varices. Prior to the procedure, when the coil was prepared, it was noted that the coil detached prematurely inside the coil sheath. There was difficulty advancing the coil. The coil was removed from the coil sheath and the procedure was completed with another of the same device. No patient complications were reported and the patient was stable post procedure. However, device analysis revealed that the interlocking arm was detached from the rest of the mail coil.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-04062 |
| MDR Report Key | 9903389 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-01-31 |
| Date Mfgr Received | 2020-03-17 |
| Device Manufacturer Date | 2019-01-14 |
| Date Added to Maude | 2020-03-31 |
| 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 | JAY JOHNSON |
| Manufacturer Street | TWO SCIMED PLACE |
| Manufacturer City | MAPLE GROVE MN 55311 |
| Manufacturer Country | US |
| Manufacturer Postal | 55311 |
| Manufacturer Phone | 7634942574 |
| Manufacturer G1 | BOSTON SCIENTIFIC CORK LIMITED |
| Manufacturer Street | MODEL FARM ROAD |
| Manufacturer City | CORK |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTERLOCK-35 |
| Generic Name | DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION |
| Product Code | KRD |
| Date Received | 2020-03-31 |
| Returned To Mfg | 2020-02-25 |
| Model Number | 83786 |
| Catalog Number | 83786 |
| Lot Number | 0023181815 |
| 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 | TWO SCIMED PLACE MAPLE GROVE MN 55311 US 55311 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-31 |