MAUDE Adverse Event Report: BIOSENSE WEBSTER INC. COOLFLOW IRRIGATION PUMP; PUMP, CIRCULATING-FLUID, LOCALIZED HEAT

Model Number	CFP002
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Pulmonary Edema (2020)
Date of Event	09/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The hardware investigation has begun but it has not been completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).
Event or Problem Description
It was reported that a (b)(6) female patient underwent an atrial fibrillation (afib) ablation procedure on (b)(6) 2020 with a coolflow® irrigation pump and suffered acute pulmonary edema.During the procedure, the cable would not allow the catheter to zero.A new cable passed off, and the catheter was able to be zeroed.Case continued without further issues.A total of 87 radiofrequency (rf) applications were done.No immediate patient consequences were reported.Same day, post-procedure, the patient developed acute pulmonary edema (ae1) and was admitted.Unspecified medication was administered.Dc cardioversion was performed.Prolonged hospitalization was required.Issue was resolved, the patient was discharged on (b)(6) 2020.The principal investigator assessed this event as moderate in severity, serious, unlikely related to the study device (qdot micro¿ catheter), not related to the study device (nmarq¿ multi-channel rf generator sw v3.0.1), unlikely related to the study device (nmarq¿ multi-channel rf generator sw v3.0.6), not related to the study device (tx eco ext interface cable (d-1357-03-si), not related to the study device (tx eco cable dongle (em-5050-055f), not related to the non-bwi investigational devices (e.G.Pump, tubing, cables, non-study catheters, etc) and probable index procedure related.Given the implied relationship of adverse event to the study device qdot micro¿ catheter and procedure, this event is to be reported under the marketed device used, the coolflow® irrigation pump, which could have contributed to the causality of the event.
Additional Manufacturer Narrative
It was reported that a 71-year-old female patient underwent an atrial fibrillation (afib) ablation procedure on (b)(6) 2020 with a coolflow® irrigation pump and suffered acute pulmonary edema.Device investigation details: the serial number of the coolflow® irrigation pump provided by the customer was not recognized as a valid serial number.Multiple follow-up attempts to clarify the unit information have been performed, but no additional information was provided.Since there is no clarification, no product investigation can be performed, and the customer complaint cannot be confirmed.Since no serial number was provided, no manufacturer record evaluation could be performed.If additional information is received regarding clarification of the system used in this event, a supplemental 3500a report will be submitted to the fda.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: COOLFLOW IRRIGATION PUMP
• Common Device Name: PUMP, CIRCULATING-FLUID, LOCALIZED HEAT
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• MDR Report Key: 11024566
• Report Number: 2029046-2020-01955
• Device Sequence Number: 3548183
• Product Code: DRF
• UDI-Device Identifier: 10846835000085
• UDI-Public: 10846835000085
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P990071/S5
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2020

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
• Operator of Device: Health Professional
• Device Model Number: CFP002
• Device Catalogue Number: CFP002
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2020
• Supplement Date Received by Manufacturer: 02/12/2021
• Initial Report FDA Received Date: 12/16/2020
• Supplement Report FDA Received Date: 02/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 8.5F SHEATH WITH CURVE VIZ SMC; CARTO 3 SYSTEM; CARTO SMARTTOUCH DONGLE; COOLFLOW TUBING SET,SINGLE PK; EXTENSION CABLE; INDIFFERENT ELECTRODE COMPATIBLE WITH NMARQ¿SYSTEM; UNK_QDOT MICRO
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 71 YR