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 2020-02-22 for INTELLANAV MIFI OPEN-IRRIGATED ABLATION CATHETER 87047 manufactured by Boston Scientific Corporation.
[180846270]
The device has not been received for analysis; therefore, a failure analysis of the complaint device could not be completed. The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.
Patient Sequence No: 1, Text Type: N, H10
[180846271]
It was reported that incorrect temperature was displayed. A nav mifi oi was selected for a flutter procedure. However during the procedure the catheter temperature out side the body was 22-24 degrees celsius but when the catheter was inserted into the body the temperature was 75 degrees without ablation. The catheter was changed to a different model. No patient complications were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-01428 |
| MDR Report Key | 9742697 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-22 |
| Date of Report | 2020-02-12 |
| Date of Event | 2020-01-16 |
| Date Mfgr Received | 2020-01-16 |
| Device Manufacturer Date | 2019-07-03 |
| Date Added to Maude | 2020-02-22 |
| 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 | INTELLANAV MIFI OPEN-IRRIGATED ABLATION CATHETER |
| Generic Name | CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER |
| Product Code | OAD |
| Date Received | 2020-02-22 |
| Model Number | 87047 |
| Catalog Number | 87047 |
| Lot Number | 0024054040 |
| 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 | 2020-02-22 |