MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-03-29 for CARTO VIZIGO? 8.5F BI-DIRECTIONAL GUIDING SHEATH - MEDIUM D138502 manufactured by Biosense Webster Inc.
[143814594]
The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.? A manufacturing record evaluation was performed for the finished device 00001054 number, and no internal action was found during the review. Manufacturer's ref. No: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[143814595]
It was reported that a patient underwent an atrial fibrillation (afib) procedure with a carto vizigo? 8. 5f bi-directional guiding sheath? Medium and the brim cap detached and hemostatic valve separated device malfunctions occurred. The sheath was inside the patient? S body and while the physician was removing the dilator, the orange cap (brim cap) on the sheath valve broke. They replaced the sheath with an agilis sheath. There was no patient consequence reported. Upon request, additional information was received on the event on (b)(6) 2019 which included a picture. They stated that the hemostatic valve (gasket) broke into two or more separate pieces and detached from the sheath. There was no excessive bleeding. After reviewing the event, additional information received and the picture, it was assessed that the brim cap being detached and the hemostatic valve being separated were reportable malfunctions.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2029046-2019-02911 |
| MDR Report Key | 8467037 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-03-29 |
| Date of Report | 2019-03-14 |
| Date of Event | 2019-03-14 |
| Date Mfgr Received | 2019-03-14 |
| Device Manufacturer Date | 2018-09-24 |
| Date Added to Maude | 2019-03-29 |
| 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 | MR. GABRIEL ALFAGEME |
| Manufacturer Street | 33 TECHNOLOGY DRIVE |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 949789-868 |
| Manufacturer G1 | BIOSENSE WEBSTER INC (IRVINE) |
| Manufacturer Street | 33 TECHNOLOGY DRIVE |
| Manufacturer City | IRIVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92618 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CARTO VIZIGO? 8.5F BI-DIRECTIONAL GUIDING SHEATH - MEDIUM |
| Generic Name | INTRODUCER, CATHETER |
| Product Code | DYB |
| Date Received | 2019-03-29 |
| Catalog Number | D138502 |
| Lot Number | 00001054 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOSENSE WEBSTER INC |
| Manufacturer Address | 33 TECHNOLOGY DRIVE IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-29 |