MAUDE Adverse Event Report: BIOSENSE WEBSTER INC QDOT-MICRO, UNI-DIRECTIONAL, F CURVE, C3, SPLIT HANDLE; SIMILAR DEVICE D134701, PMA # P030031/S078

Catalog Number D139402

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Fever (1858)

Event Date 05/01/2021

Event Type  Injury  

Manufacturer Narrative

Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.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

During a clinical trial, sponsored by biosense webster, inc (bwi), it was reported that a (b)(6) male patient underwent an atrial fibrillation (afib) ablation procedure with a qdot-micro, uni-directional, f curve, c3, split handle and suffered a fever requiring prolonged hospitalization which required medication treatment.The patients medical history is unknown.The patient was admitted to the hospital on (b)(6) 2021 and was discharged on (b)(6) 2021.The patient was reported to have recovered.Based on the narrative, there were no complaints of device malfunction.It was reported that the adverse event may possibly be procedure related.

Manufacturer Narrative

Additional information was received on (b)(6)2021 and it was reported that the patient experienced a fever on (b)(6)2021 requiring prolonged hospitalization until (b)(6)2021.Medication treatment was required.The outcome of this adverse event was reported as recovered/resolved on (b)(6)2021.A serious deterioration in the health of the subject was reported.Medication treatment was required.There were no medical or surgical intervention conducted.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

• Brand Name: QDOT-MICRO, UNI-DIRECTIONAL, F CURVE, C3, SPLIT HANDLE
• Type of Device: SIMILAR DEVICE D134701, PMA # P030031/S078
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• MDR Report Key: 12063102
• MDR Text Key: 266311351
• Report Number: 2029046-2021-00994
• 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: foreign,study
• Type of Report: Initial,Followup
• Report Date: 05/28/2021

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 Catalogue Number: D139402
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/28/2021
• Initial Date FDA Received: 06/24/2021
• Supplement Dates Manufacturer Received: 07/09/2021
• Supplement Dates FDA Received: 08/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LASSO NAV 2515,22P SPLITHANDLE; NGEN RF GENERATOR; NON-BWI SHEATH; UNK_CARTO 3
• Patient Outcome(s): Hospitalization
• Patient Age: 62 YR