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 2020-03-26 for INTELLANAV MIFI OPEN-IRRIGATED 87047 manufactured by Boston Scientific Corporation.
[187707395]
It was indicated that the device will not be returned for evaluation. If there is any further relevant information obtained, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[187707396]
It was reported that the patient experienced a pericardial effusion. During a pulmonary vein isolation (pvi) ablation procedure with an intellanav mifi open-irrigated catheter to treat atrial fibrillation, pvi was nearly finished but the physician had problems reaching the anterior part of the right inferior pulmonary vein (ripv) ostium. He tried to maneuver the catheter to the desired spot several minutes, but could not get there. Resistance was felt when the physician tried to reach the anterior wall at ripv ostium. Another physician took over and realized that the catheter wasn't located in the left atrium anymore, but was withdrawn into the right atrium. Then, the blood pressure of the patient dropped and they discovered a pericardial effusion. They performed a pericardiocentesis, but the hole was closed within a few minutes and the patient's blood pressure was good again. After that the patient woke up, they were orientated and able to communicate. The patient fully recovered. The physician was convinced that the perforation happened because he did not realize that the catheter was in the right atrium, and tried to reach an anterior part of the left atrium. Therefore, he pushed too hard with the catheter within the non-boston scientific sheath and that made it really stiff and inflexible. It was not related to any malfunction of the catheter. The catheter was disposed of, and is therefore not available for return.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 2134265-2020-03926 |
MDR Report Key | 9884474 |
Report Source | COMPANY REPRESENTATIVE,FOREIG |
Date Received | 2020-03-26 |
Date of Report | 2020-03-26 |
Date of Event | 2020-02-27 |
Date Mfgr Received | 2020-02-27 |
Date Added to Maude | 2020-03-26 |
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 |
Generic Name | CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER |
Product Code | OAD |
Date Received | 2020-03-26 |
Model Number | 87047 |
Catalog Number | 87047 |
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 | 1. Required No Informationntervention | 2020-03-26 |