MAUDE Adverse Event Report: BIOSENSE WEBSTER INC QDOT-MICRO, BI-DIRECTIONAL, D-F CURVE, C3, SPLIT HANDLE CATHETER; QDOT MICRO

Catalog Number D139505

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems ST Segment Elevation (2059); Ventricular Tachycardia (2132)

Event Date 02/07/2020

Event Type  Injury  

Manufacturer Narrative

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).

Event Description

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.

Manufacturer Narrative

It was reported that a 68 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.The biosense webster inc.Product analysis lab received a picture for evaluation.The picture investigational analysis completed 3/6/2020.According to pictures provided by customer, procedure graph was observed on carto 3 screen, generator parameters, and id label.Photo does not provide enough information related to the reported event.Therefore no result can be obtained from it.A manufacturing record evaluation was performed and no internal actions were identified.The customer complaint cannot be confirmed based on the picture.Root cause of adverse event remains unknown.However, the device has not been returned for analysis.Therefore, it is not possible to determine the root cause of the failure.If the device is received in the future, the product analysis will be performed.Manufacture reference no: (b)(4).

Manufacturer Narrative

Correction: the complaint product was returned to biosense webster inc.¿s (bwi) product analysis lab (pal) for evaluation on 2/21/2020.This information was inadvertently omitted in supplemental follow-up # 1.As such, field 10.Device available for evaluation? has now been populated to ¿yes¿, 10.Date device returned to manufacturer has been populated to 2/21/2020 and 10.Is device returned to manufacturer? has been checked.Device evaluation details: the device evaluation has been completed.The device was visually inspected and it was found in good conditions.The magnetic and temperature features were tested and no issues were observed.In addition, the catheter was deflecting and irrigating correctly.Force feature failed as error 106 was observed.Failure analysis was performed and the catheter was dissected on the tip area, loss of electrical continuity at the sensor was found, it was determined that the root cause was an internal failure of the sensor.A manufacturing record evaluation was performed and no internal actions related to the reported complaint were identified.The customer complaint cannot be confirmed.The root cause of the adverse event remains unknown.The instructions for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation or tamponade.The root cause of the internal failure of the sensor cannot be determined.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

• Brand Name: QDOT-MICRO, BI-DIRECTIONAL, D-F CURVE, C3, SPLIT HANDLE CATHETER
• Type of Device: QDOT MICRO
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 9788009
• MDR Text Key: 188234113
• Report Number: 2029046-2020-00350
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 02/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/24/2020
• Device Catalogue Number: D139505
• Device Lot Number: 30267588L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2020
• Initial Date Manufacturer Received: 02/07/2020
• Initial Date FDA Received: 03/04/2020
• Supplement Dates Manufacturer Received: 03/06/2020; 05/07/2020
• Supplement Dates FDA Received: 04/01/2020; 06/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM; COOL FLOW PUMP,EUROPE SHIP KIT; NMARQ GENERATOR SYSTEM; PENTARAY NAV ECO 7FR, F, 4-4-4; ST. JUDE MEDICAL, MEDCURL AGILIS NXT 8.5F SHEATH
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 50