MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (IRWINDALE) COOLFLOW; CATHETER, ELECTRODE RECORDING

Model Number	D-1233-01-S
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/30/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Since the product was not returned for analysis, 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 the complaint device is received in the future we will reopen the complaint and perform the investigation as appropriate.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.Due to the (b)(6) 2015 fda maintenance where the 3500a codes were updated, the 3500a codes will be added to h10 until the biosense webster system is also updated.(b)(4).
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation (afib) procedure with a coolflow tubing set.Before setting the tube, it was found that there was red blob in the tube of the connection side at t shape stopcock.It seems that the red ink was adhered which was emblazoned on the t shape stopcock.The issue was resolved by changing the tubing set to another one.The procedure was completed with no patient consequence.Since there was foreign material found inside the tubing, this issue has been assessed as a reportable malfunction as it can cause embolism or stroke.
Additional Manufacturer Narrative
The bwi failure analysis lab received the device for evaluation on 8/1/2016.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.(b)(4).
Additional Manufacturer Narrative
(b)(4).It was reported that a patient underwent an atrial fibrillation (afib) procedure with a coolflow tubing set.Before setting the tube, it was found that there was red blob in the tube of the connection side at t shape stopcock.It seems that the red ink was adhered which was emblazoned on the t shape stopcock.The issue was resolved by changing the tubing set to another one.The procedure was completed with no patient consequence.The visual inspection was performed and the biosense webster failure analysis lab did not find any "red blob" issues with the tubing or with the stop cock.The stop cock has red arrows for direction and an "off" word to show when the tubing is turned off when it is not in use.A visual was performed and the tubing is fine and the stop cock is also fine with no other issues found with the 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.The complaint was not confirmed.

• Brand Name: COOLFLOW
• Common Device Name: CATHETER, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER, INC. (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• MDR Report Key: 5817753
• Report Number: 2029046-2016-00086
• Device Sequence Number: 13792232
• Product Code: DRF
• UDI-Device Identifier: 10846835000016
• UDI-Public: (01)10846835000016(11)160309(17)170228(10)774036
• 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
• Report Date (Section B): 07/04/2016

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: 02/28/2017
• Device Model Number: D-1233-01-S
• Device Catalogue Number: CFT001
• Device Lot Number: OEM_D-1233-01-S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2016
• Was the Report Sent to FDA?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/30/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 07/22/2016
• Supplement Report FDA Received Date: 08/05/2016; 09/29/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1