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

Catalog Number	CFT001
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's ref.No: (b)(4).
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation (afib) procedure with a coolflow tubing set.During set-up, foreign material was noticed on the tip of the tubing before use.The tubing was replaced and the procedure continued without patience consequence.Additional information has been received and it confirmed that the tubing was not used in the procedure.The foreign material on the tip of the tubing was assessed as a reportable issue.
Additional Manufacturer Narrative
The biosense webster inc.Failure analysis lab received the device for evaluation on 12/11/2018.Therefore, populated device available for evaluation?, is device returned to manufacturer? and date device returned to manufacturer.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).
Additional Manufacturer Narrative
The device history record was provided on (b)(6)2019.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.Manufacturer's ref.No: (b)(4).
Additional Manufacturer Narrative
Investigation summary: it was reported that a patient underwent an atrial fibrillation (afib) procedure with a coolflow tubing set.During set-up, foreign material was noticed on the tip of the tubing before use.The tubing was replaced and the procedure continued without patience consequence.Additional information has been received and it confirmed that the tubing was not used in the procedure.The tubing was sent to the analysis lab.The lab inspected the tubing and found the tubing in normal condition.There was no foreign material found in the tubing.The lab performed the irrigation test and results were within specification.All results passed.Lab could not reproduce the failure.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.Manufacturer¿s reference number: (b)(4).

• Brand Name: COOLFLOW TUBING SET
• Common Device Name: CATHETER, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 8144736
• Report Number: 2029046-2018-02429
• Device Sequence Number: 11238019
• Product Code: DRF
• UDI-Device Identifier: 10846835000016
• UDI-Public: 10846835000016
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup,Followup
• Report Date (Section B): 11/13/2018

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: 04/30/2019
• Device Catalogue Number: CFT001
• Device Lot Number: 05180324
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2018
• Initial Date Received by Manufacturer: 11/13/2018
• Supplement Date Received by Manufacturer: 12/11/2018; 01/15/2019; 02/22/2019
• Initial Report FDA Received Date: 12/08/2018
• Supplement Report FDA Received Date: 12/12/2018; 01/16/2019; 03/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1