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

Catalog Number	CFP002
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/28/2019
Type of Reportable Event	Malfunction
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.Manufacturer's reference # (b)(4).
Event or Problem Description
Event description: during an ide (qdot) clinical study sponsored by biosense webster, inc.During an atrial fibrillation (afib) paroxysmal procedure with a coolflow® irrigation pump, a high flow rate activation problem with ablation malfunction occurred.It was reported that when using q mode with the coolflow® irrigation pump, it would not switch to high irrigation.The maximum temperature was decreased and the power was increased to 35 watts; however, the issue remained.The case was completed successfully having reduced power being delivered to the catheter.There was no patient consequence reported.Additional information was received on the event stating that the pump did not switch to high flow when the ablation was initiated.The coolflow® irrigation pump did not display an error and continued ablating at a lower flow.The issue of high flow rate activation problem with ablation was assessed as a reportable event.
Additional Manufacturer Narrative
Investigation summary: during an ide (qdot) clinical study sponsored by biosense webster, inc.During an atrial fibrillation (afib) paroxysmal procedure with a coolflow® irrigation pump, a high flow rate activation problem with ablation malfunction occurred.It was reported that when using q mode with the coolflow® irrigation pump, it would not switch to high irrigation.The maximum temperature was decreased, and the power was increased to 35 watts; however, the issue remained.The case was completed successfully having reduced power being delivered to the catheter.The device was evaluated, and there were no errors found.The device performed within specification.The certificate of conformance (coc) was reviewed and it was verified that the device was manufactured in accordance with documented specification and procedures.The customer complaint could not be confirmed.Manufacturer's reference # (b)(4).
Additional Manufacturer Narrative
Additional information was received on(b)(6)2019 and it was noted that the patient was a 75 year old female patient.Therefore, section a2.Patient age at the time of event was populated with 75, section a2.Age unit was populated with years and section a3.Sex was populated with f.Manufacturer's reference # pc-000472537.

• 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: 8723370
• Report Number: 2029046-2019-03288
• Device Sequence Number: 1860435
• Product Code: DRF
• UDI-Device Identifier: 10846835000085
• UDI-Public: 10846835000085
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P990071/S5
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: CFP002
• Initial Date Received by Manufacturer: 05/28/2019
• Supplement Date Received by Manufacturer: 07/16/2019; 07/17/2019
• Initial Report FDA Received Date: 06/21/2019
• Supplement Report FDA Received Date: 08/08/2019; 09/16/2019
• 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: NMARQ¿ MULTI-CHANNEL RF GENERATOR.; QDOT MICRO, UNI, TC, F, IDE.; TX ECO CABLE DONGLE.; TX ECO EXT INTERFACE CABLE.
• Patient Age: 75 YR