MAUDE Adverse Event Report: BIOSENSE WEBSTER INC COOLFLOW® IRRIGATION PUMP; SIMILAR DEVICE CFP002, PMA # P990071/S5

Catalog Number CFP001

Device Problem Device Alarm System (1012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/06/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Attempts have been made to obtain product information for the cool flow pump used during this procedure.Since there is no product information, no product failure analysis can be conducted and no determination of possible contributing factors could be made.As such the investigation will be closed.If additional information is received regarding clarification of the system used in this event, the complaint will be reopen and investigation will be performed and a supplemental 3500a report will be submitted to the fda.Since no serial number was provided, no medical record evaluation (mre) could be performed manufacturer's reference #: (b)(4).

Event Description

It was reported that a patient underwent a pulmonary vein isolation (pvi) procedure with a coolflow® irrigation pump and it was reported that there was low flow without error message.It was initially reported that during the pulmonary vein isolation (pvi) the smartablate¿ system gave bubble error.The smartablate¿ system did not give warning for the empty saline bag, therefore, there were bubbles in the tubing.The catheter was flushed, and ablation was restarted.Almost immediately, the tubing was found to have bubbles again.This was done a total of 3 times with the same outcome.The issue of low flow without error message was assessed as a reportable event.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.

• Brand Name: COOLFLOW® IRRIGATION PUMP
• Type of Device: SIMILAR DEVICE CFP002, PMA # P990071/S5
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer Contact: gabriel alfageme ; 33 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 8569776
• MDR Text Key: 145962967
• Report Number: 2029046-2019-03043
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 04/01/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: CFP001
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/01/2019
• Initial Date FDA Received: 05/01/2019
• 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: Reuse
• Patient Sequence Number: 1