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 Patient Device Interaction Problem (4001)

Patient Problem Fever (1858)

Event Date 07/08/2021

Event Type  Injury  

Manufacturer Narrative

Information received indicates that the device is not available for return, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation (mre) cannot be conducted because no valid lot number was provided by the customer.Note: the provided lot number was not recognized as a valid lot number in our system, as such, the manufactured date and the expiration dates could not be obtained.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Note: the ¿suspected medical device¿ reported 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 thermocool® smart touch¿ electrophysiology catheter approved under p030031/s053.Initial reporter phone: (b)(6).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Event Description

It was reported that a (b)(6) year-old female underwent an atrial fibrillation (afib) ablation procedure with a qdot-micro, bi-directional, d-f curve, c3, split handle and the patient developed a fever requiring medication and prolonged hospitalization.It was reported the patient developed a fever which required antibiotic therapy and prolonged hospitalization.The adverse event was assessed as unlikely related to the study device and probably related to the procedure and not related to any other procedure.Patient¿s admission date: (b)(6) 2021 & discharge date: (b)(6) 2021.

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).Correction: on 7-jan-2022, it was noticed that the following information was inadvertently omitted from the 3500a initial medwatch report: on 16-jul-2021 and 18-jul-2021 additional information was received indicated the principal investigator assessed this event index procedure related and moderate in severity.The event was expected/anticipated.No medication was required other than the antibiotic therapy.The patient¿s outcome was reported as recovered/resolved.

• 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; 31 technology drive, suite 200; 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 dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12311322
• MDR Text Key: 273557927
• Report Number: 2029046-2021-01334
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/31/2022

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: D139505
• Device Lot Number: 30224686LA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/21/2021
• Initial Date FDA Received: 08/12/2021
• Supplement Dates Manufacturer Received: 01/07/2022
• Supplement Dates FDA Received: 01/31/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female