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 2020-03-25 for GUIDEZILLA 1867 manufactured by Boston Scientific Corporation.
[185043337]
Device evaluated by manufacturer: the device was returned for analysis. Returned product consisted of a guidezilla guide extension catheter. The hypotube, collar, distal shaft and tip was microscopically and visually inspected. Visual inspection revealed a separation at the collar and there are multiple kinks along the hypotube. Microscopic inspection revealed no additional damages. Inspection of the remainder of the device presented no other damage or irregularities.
Patient Sequence No: 1, Text Type: N, H10
[185043338]
Reportable based on device analysis completed on 18mar2020. It was reported that the guidezilla could not cross the lesion. A 16mm x 2. 0mm, 99% stenosed target lesion was located in the mildly tortuous and moderately calcified left circumflex artery. A 5-in-6 guidezilla was selected for use in a percutaneous coronary intervention. During procedure, it was noted that the guidezilla could not cross the lesion. The procedure was completed with another of the same device. No patient complications were reported and patient status was stable. However, device analysis revealed a separation of the collar.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-03763 |
| MDR Report Key | 9878146 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-01-16 |
| Date Mfgr Received | 2020-03-18 |
| Device Manufacturer Date | 2019-07-02 |
| Date Added to Maude | 2020-03-25 |
| 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 SCIMED, INC |
| Manufacturer Street | TWO SCIMED PLACE |
| Manufacturer City | MAPLE GROVE MN 55311 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55311 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GUIDEZILLA |
| Generic Name | CATHETER, PERCUTANEOUS |
| Product Code | DQY |
| Date Received | 2020-03-25 |
| Returned To Mfg | 2020-02-24 |
| Model Number | 1867 |
| Catalog Number | 1867 |
| Lot Number | 0024045736 |
| 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 | 2020-03-25 |