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 2020-01-28 for EZ BENT TIP 7584 manufactured by Boston Scientific Corporation.
[176630210]
(b)(6).
Patient Sequence No: 1, Text Type: N, H10
[176630211]
It was reported that a fragment of the device remained inside the patient's body. The target lesion was located in the internal carotid artery. A ez bent tip filterwire was selected for use. During procedure, the filterwire was deployed in the distal lesion. Pre-dilatation and stent placement were completed. Angiography was performed and apposition to vessel wall was confirmed. When the filterwire was tried to retrieve using the retrieval sheath, it became caught inside the stent, and it was unable to retrieve. The bent tip device was removed and retrieval was tried to perform, however, it still caught at the same location, and it was unable to retrieve. Dock replacement was done and retrieval was performed using the bent tip device, but still caught at the same location. Repetitive push and pull were done, eventually the filterwire dropped slightly, however the loop remained open. After that, approach was tried to perform using bent tip, but the marker of the bent tip device slipped through the filterwire, and it reached up to m1. The filterwire was removed forcibly while being deployed, and the protruding tip was retrieved. Stent retriever, snare, and aspiration catheter were fully used, but it flowed to m2, and could not be retrieved. The procedure was ended with the fragment left inside the patient's body. No further patient complications were reported and patient was stable post procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-00595 |
| MDR Report Key | 9636533 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-28 |
| Date of Report | 2020-03-13 |
| Date of Event | 2020-01-08 |
| Date Mfgr Received | 2020-02-28 |
| Device Manufacturer Date | 2019-05-14 |
| Date Added to Maude | 2020-01-28 |
| 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 DE COSTA RICA S.R.L |
| Manufacturer Street | 2546 CALLE PRIMERA |
| Manufacturer City | ALAJUELA |
| Manufacturer Country | CS |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EZ BENT TIP |
| Generic Name | TEMPORARY CORONARY SAPHENOUS VEIN BYPASS GRAFT FOR EMBOLIC PROTECTION |
| Product Code | NFA |
| Date Received | 2020-01-28 |
| Returned To Mfg | 2020-01-30 |
| Model Number | 7584 |
| Catalog Number | 7584 |
| Lot Number | 0023792326 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 1. Other | 2020-01-28 |