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 2020-03-24 for INTELLATIP MIFI OPEN-IRRIGATED 86493 manufactured by Boston Scientific Corporation.
[184807893]
Visual inspection revealed a rust color under the proximal seal of ring 1 and under both edges of the electrode. There were dried body fluid found on the handle, main shaft and distal end. Dried saline found on the distal end and inside several irrigation ports. Electrical testing revealed all electrodes, sensor and thermocouple resistances measured within specification and were typical. The functional testing revealed an abnormal resistance was felt when actuating the steering mechanism. The lumen pressure decay was measured and were found to be below the maximum acceptable limit. The x-ray inspection showed no anomalies. The catheter was dissected and all the ring electrodes were removed. Only ring 1 had rust color under the electrode.
Patient Sequence No: 1, Text Type: N, H10
[184807894]
Reportable based on device analysis completed on 26feb2020. It was reported that the catheter could not apply current. During an ablation procedure to treat atrial flutter in the heart a intellatip mifi open-irrigated catheter was selected for use. When energization was performed, the temperature was displayed as lo, and could not apply current, therefore the catheter was replaced and the ablation was successfully completed without patient complications. However, device analysis revealed the ring 1 proximal seal was partially separated from the electrode allowing fluid to enter into the distal end cavity.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-03753 |
| MDR Report Key | 9873221 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-24 |
| Date of Report | 2020-03-24 |
| Date of Event | 2020-01-10 |
| Date Mfgr Received | 2020-02-26 |
| Device Manufacturer Date | 2018-12-13 |
| Date Added to Maude | 2020-03-24 |
| 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, LA AURORA, |
| Manufacturer City | HEREDIA |
| Manufacturer Country | CS |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTELLATIP MIFI OPEN-IRRIGATED |
| Generic Name | CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER |
| Product Code | OAD |
| Date Received | 2020-03-24 |
| Returned To Mfg | 2020-01-27 |
| Model Number | 86493 |
| Catalog Number | 86493 |
| Lot Number | 0023080503 |
| 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 | 300 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-24 |