MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,s report with the FDA on 2020-03-25 for INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER 87035 manufactured by Boston Scientific Corporation.
[186515324]
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
[186515325]
Localize pm007 clinical study. It was reported that the patient experienced pneumonia, "cardial decomposition," pain in the lower stomach, ascites and pleural effusion following an ablation procedure with an intellanav mifi open-irrigated ablation catheter, an intellamap orion high resolution mapping catheter, a tsx fixed curve sheath, an ep-xt diagnostic catheter and a non-boston scientific steerable introducer. The patient was given intravenous or intramuscular antibiotics and the event resolved. The suspected cause was exertional dyspnea after ablation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-03869 |
| MDR Report Key | 9878895 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,S |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-01-21 |
| Date Mfgr Received | 2020-03-10 |
| Device Manufacturer Date | 2018-10-19 |
| Date Added to Maude | 2020-03-25 |
| 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 | INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER |
| Generic Name | CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING |
| Product Code | DRF |
| Date Received | 2020-03-25 |
| Model Number | 87035 |
| Catalog Number | 87035 |
| Lot Number | 0022819728 |
| Device Expiration Date | 2019-10-19 |
| 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 | 2020-03-25 |