MAUDE Adverse Event Report: BIOSENSE WEBSTER INC QDOT-MICRO, BI-DIRECTIONAL, D-F CURVE, C3, SPLIT HANDLE; SIMILAR DEVICE D134801, PMA # P030031/S078

Catalog Number D139505

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

Patient Problems Cardiac Tamponade (2226); No Code Available (3191)

Event Date 06/26/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 30263015l number, and no internal action related to the complaint was found during the review.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent persistent atrial fibrillation (afib) ablation procedure with a qdot-micro, bi-directional, d-f curve, c3, split handle catheter and suffered cardiac tamponade requiring surgical intervention.At the end of the procedure, a pericardial effusion was diagnosed with a transesophageal ultrasound.Pericardiocentesis was performed and the patient transferred to the cardiovascular operating room (ccv) for surgery (ongoing at the time of the call).No information was provided regarding the final outcome.The event was discovered post use of biosense webster product after ablation was performed.There was no evidence of steam pop.In the physician¿s opinion, the cause of this adverse event patient¿s condition (specific anatomy of the left atrial appendage).Surgical intervention in the form of sternotomy and suture of the lesion in the left atrium.Extended hospitalization was required.Transseptal was performed with baylis torflex needle (tf85-32-63-55).The irrigation flow was set at 4-15ml/min (qdot).There were no error messages displayed on biosense webster equipment during the procedure.The visitag module was used with stability parameters 3mm for 3s force-over-time 25% 3g, ablation index = 400.No additional filters were used.Tag color set by tag index.

• Brand Name: QDOT-MICRO, BI-DIRECTIONAL, D-F CURVE, C3, SPLIT HANDLE
• Type of Device: SIMILAR DEVICE D134801, PMA # P030031/S078
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: gabriel alfageme ; 31 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 10315951
• MDR Text Key: 200280780
• Report Number: 2029046-2020-00927
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/26/2020

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: 12/09/2020
• Device Catalogue Number: D139505
• Device Lot Number: 30263015L
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/26/2020
• Initial Date FDA Received: 07/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention