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 2020-03-04 for QDOT-MICRO, BI-DIRECTIONAL, D-F CURVE, C3, SPLIT HANDLE CATHETER D139505 manufactured by Biosense Webster Inc.
[188234113]
The qdot-micro, bi-directional, d-f curve, c3, split handle catheter reported in section d of this report is not marketed in usa or approved by the fda. However, it is being reported as biosense webster considers this as a similar device to stsf: thermocool smarttouch? Sf catheters approved under p030031/s072. Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made. If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda. Manufacture reference no: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[188234114]
It was reported that a (b)(6) year old female patient underwent a field preference cardiac ablation procedure with a qdot-micro, bi-directional, d-f curve, c3, split handle catheter and suffered coronary artery spasms requiring coronary angiography. During the ablation in the vicinity of a coronary artery the patient had st depression and developed atrial fibrillation. Coronary artery angiography was ordered to check the coronary arteries. Nothing was detected which is why it was concluded that it was a coronary spasm. The patient fully recovered, with no residual effects, except few slow ventricular tachycardias. No unintended ablation was performed. This adverse event was discovered during use of biosense webster products. The opinion of the physician was that the event was procedure related. The physician commented that maybe he should have used less power (50w with qdot) with retrograde loop in a patient with about 50kg. It was also reported that during ablation the queue dot of the respiration gating turned grey and there was no ablation index or ablation point until the ablation stopped. During most of the procedure the respiratory gating data was available. The caller was not certain whether the respiratory gating data was available at those ablation points where the ablation index was not shown. The visitag information was visible for one point in the graphs viewer. The other to it wasn? T available. In this case the point appeared but did not get an ablation index value. Visitag was used for force visualization with stability settings (for the cti): 3mm,3s, 30% 4g, tag index enable: low 500, high 550, impedance drop (5ohm low- 10 high) filter and impedance for color. This event will be conservatively reported under the ablation catheter.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2029046-2020-00350 |
| MDR Report Key | 9788009 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-04 |
| Date of Report | 2020-02-07 |
| Date of Event | 2020-02-07 |
| Date Mfgr Received | 2020-03-06 |
| Device Manufacturer Date | 2019-11-25 |
| Date Added to Maude | 2020-03-04 |
| 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 | MR. GABRIEL ALFAGEME |
| Manufacturer Street | 31 TECHNOLOGY DRIVE |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 949789-868 |
| Manufacturer G1 | BIOSENSE WEBSTER INC (JUAREZ) |
| Manufacturer Street | CIRCUITO INTERIOR NORTE 1820PARQUE INDUSTRIAL SALVACAR |
| Manufacturer City | JUAREZ 32599 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 32599 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | QDOT-MICRO, BI-DIRECTIONAL, D-F CURVE, C3, SPLIT HANDLE CATHETER |
| Generic Name | QDOT MICRO |
| Product Code | DRF |
| Date Received | 2020-03-04 |
| Catalog Number | D139505 |
| Lot Number | 30267588L |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOSENSE WEBSTER INC |
| Manufacturer Address | 33 TECHNOLOGY DRIVE IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-04 |