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 2020-03-18 for BLAZER II 85020 manufactured by Boston Scientific Corporation.
[184039960]
The device has not been received for analysis. Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[184039961]
It was reported the catheter was unable to sense temperature. During an ablation procedure to treat supraventricular tachycardia (svt) in the left atrium (la), the physician was unable to ablate with two different blazer ii 4mm catheters. The catheters were not sensing temperature at all. The impedance was sensing appropriately, but because temperature was not, they were unable to ablate. An attempt at ablation was made but was unsuccessful. There was no mapping system involved, this was a conventional electrophysiology (ep) procedure. The ablation time was 0 seconds when the issue occurred. The issue was persistent from the start of ablation and therefore the catheters were not usable. The generator was used in power mode, but it was unknown at what output. No error message displayed. No patient complications occurred. The procedure was completed with another manufacturer's catheter.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-03533 |
| MDR Report Key | 9849997 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-18 |
| Date of Report | 2020-03-18 |
| Date of Event | 2020-03-04 |
| Date Mfgr Received | 2020-03-06 |
| Device Manufacturer Date | 2019-05-03 |
| Date Added to Maude | 2020-03-18 |
| 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 | TIMOTHY DEGROOT |
| Manufacturer Street | 4100 HAMLINE AVENUE NORTH DC A330 |
| Manufacturer City | SAINT PAUL MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 6515826168 |
| Manufacturer G1 | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Street | 302 PARKWAY, GLOBAL PARK |
| Manufacturer City | LA AURORA - HEREDIA |
| Manufacturer Country | CS |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BLAZER II |
| Generic Name | CARDIAC ABLATION PERCUTANEOUS CATHETER |
| Product Code | LPB |
| Date Received | 2020-03-18 |
| Model Number | 85020 |
| Catalog Number | 85020 |
| Lot Number | 0023740787 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | 300 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-18 |