MAUDE Adverse Event Report: BIOSENSE WEBSTER INC COOLFLOW TUBING SET,SINGLE PK; CATHETER, ELECTRODE RECORDING

Catalog Number	CFT001
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The bwi failure analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.Manufacturer's ref.No: (b)(4).
Event or Problem Description
It was reported that a patient underwent an ablation procedure with a coolflow tubing set and during setup, dirt was seen in the tube.The tubing set was changed, and the issue resolved.The procedure was completed with no patient consequence.This event has been assessed as a reportable malfunction.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.
Additional Manufacturer Narrative
It was reported that a patient, underwent an ablation procedure with a coolflow tubing set and during setup, dirt was seen in the tube.The tubing set was changed, and the issue resolved.Product evaluation details: the investigational analysis has been completed.Upon receipt, the product was visually inspected and it was found in normal conditions.No dirt or any foreign material was found on or in the tubing.Flow test performed, and product passed all specification.No error or bubble found in tubing.The device history record (dhr) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.Complaint was unable to be duplicated.Manufacturer's ref # (b)(4).

• Brand Name: COOLFLOW TUBING SET,SINGLE PK
• Common Device Name: CATHETER, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 7840029
• Report Number: 2029046-2018-02010
• Device Sequence Number: 11347011
• Product Code: DRF
• UDI-Device Identifier: 10846835000016
• UDI-Public: 10846835000016
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P990071/S5
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2018

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 Expiration Date: 12/31/2018
• Device Catalogue Number: CFT001
• Device Lot Number: 01180252
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2018
• Initial Date Received by Manufacturer: 08/01/2018
• Supplement Date Received by Manufacturer: 09/10/2018
• Initial Report FDA Received Date: 08/31/2018
• Supplement Report FDA Received Date: 10/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1