MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2020-03-06 for INTELLATIP MIFI XP TEMPERATURE ABLATION CATHETER 87166 manufactured by Boston Scientific Corporation.
[182428520]
The device was returned for analysis. The unit was returned in a generic plastic bag. Overall visual inspection did not identify failures or evidence that could be lost due to decontamination process. A rust colored section was observed under ring 1 electrode, and broken ring adhesive. The device had a kink at the distal section approximately at 1. 5 cm from the distal tip while in the neutral position. The steering knob and the tension control knob functioned properly on both lock and unlock positions. No abnormal resistance was felt when actuating the steering mechanism. Both right and left curves failed to reach the specified area of the template, the device failed the dimensional test. Bent center support was observed under x-ray between ring #1 and ring #2 in the same location of the kink at the distal section. A steering wire partially detached from the center support due to broken solder joint was also observed. Guide coil collapse was observed under x-ray within the handle next to the tension screw. Distal end was dissected and was confirmed bent center support in the same location of the kink at the distal section. The kevlar wrap was found retracted. A steering wire partially detached from the center support due to broken solder joint was also observed. The kevlar wrap was exposed in order to measure it and the result was: within specification, the kevlar wrap was found out of specification. Foreign debris were also found in the same location of the kink at the distal section, indicating fluid ingress.
Patient Sequence No: 1, Text Type: N, H10
[182428521]
Reportable based on device analysis completed 7feb2020. It was reported that the tip of the catheter was deformed. During a procedure to ablate the cavotricuspid isthmus (cti) for atrial flutter with the intellatip mifi xp catheter, it was found that the catheter tip was deformed. No serious injuries or adverse patient effects occurred. Device analysis revealed evidence of fluid ingress.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-02712 |
| MDR Report Key | 9799282 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-03-06 |
| Date of Report | 2020-03-06 |
| Date of Event | 2019-11-26 |
| Date Mfgr Received | 2020-02-07 |
| Device Manufacturer Date | 2017-04-19 |
| Date Added to Maude | 2020-03-06 |
| 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 | INTELLATIP MIFI XP TEMPERATURE ABLATION CATHETER |
| Generic Name | CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER |
| Product Code | OAD |
| Date Received | 2020-03-06 |
| Returned To Mfg | 2020-01-20 |
| Model Number | 87166 |
| Catalog Number | 87166 |
| Lot Number | 0020469944 |
| Device Expiration Date | 2020-03-29 |
| 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 | 2020-03-06 |