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 2020-03-30 for INTERLOCK 83779 manufactured by Boston Scientific Corporation.
[185665302]
(b)(6). Device evaluated by manufacturer: the device was returned for analysis. A pusher wire, coil , introducer sheath and microcatheter were returned for this complaint. One section of the coil returned outside the microcatheter. The microcatheter was found damaged (stretched and detached). The coil and pusher wire were stuck inside the microcatheter. It was necessary to cut the microcatheter in order to release the coil and pusher wire. The pusher wire and main coil were found stretched and the interlocking arm from the main coil was detached. No more damages were found in the device. Microscopic inspection was performed on pusher wire and main coil. The zap tip had a smooth surface. The interlocking arm was inspected and no anomalies was noted. However, the interlocking arm was found detached for the main coil. Dimensional inspection of main coil was within specification. However, there were fiber bundles missing. The fiber loss was due to the coil stretching.
Patient Sequence No: 1, Text Type: N, H10
[185665303]
Reportable based on device analysis completed on 25mar2020. It was reported that the hub of the microcatheter snapped. A 4mm x 15cm interlock was selected for use. During preparation, a direxion 021 microcatheter for a type ii endo leak was inserted, upon deployment of the interlock 018, it was noted that the nitinol sleeve snapped off. The coil and microcatheter were retrieved out from the patient's body without injury. The procedure was completed with a different device. No patient complications were reported and the patient was stable. However, device analysis revealed that fiber bundles are missing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-04003 |
| MDR Report Key | 9898026 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2019-12-18 |
| Date Mfgr Received | 2020-03-25 |
| Device Manufacturer Date | 2019-06-27 |
| Date Added to Maude | 2020-03-30 |
| 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 |
| Generic Name | DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION |
| Product Code | KRD |
| Date Received | 2020-03-30 |
| Returned To Mfg | 2020-02-24 |
| Model Number | 83779 |
| Catalog Number | 83779 |
| Lot Number | 0024024876 |
| 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 | 2020-03-30 |