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

Model Number	D-1233-01-S
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/03/2017
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.Concomitant products: unspecified smart touch sf catheter.(b)(4).
Event or Problem Description
It was reported that a patient underwent a procedure for atrial fibrillation with a coolflow tubing set where foreign material was found inside the tube.During the procedure, after connecting the catheter to the tubing set, the physician attempted to prime the tubing.At this time, a foreign substance was seen in the tube.The tubing set was exchanged for another, and the procedure continued without patient consequence.Foreign material inside a tubing set can potentially cause embolism or stroke.As a result, this event is mdr reportable.
Additional Manufacturer Narrative
On 8/10/2017, 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.(b)(4).
Additional Manufacturer Narrative
On 8/4/2017, biosense webster became aware that the lot number that was originally reported was incorrect.The lot number was updated to 986027.As a result, the lot, manufacturing/expiration date and udi fields were updated.The device analysis is still in progress.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Manufacturer's reference number: (b)(4).It was reported that a patient underwent a procedure for atrial fibrillation with a coolflow tubing set where foreign material was found inside the tube.Upon receipt, the product was visually inspected, and was found in normal condition.A flow test was performed, and the product passed all specifications.No errors displayed, and no bubbles/foreign material were found in 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 customer complaint could not be confirmed.

• Brand Name: COOLFLOW TUBING SET
• Common Device Name: CATHETER, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER, INC. (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• MDR Report Key: 6721757
• Report Number: 2029046-2017-00231
• Device Sequence Number: 16486859
• Product Code: DRF
• UDI-Device Identifier: 10846835000016
• UDI-Public: (01)10846835000016(11)170209(17)180131(10)988027
• 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): 07/03/2017

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: 01/31/2018
• 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: 08/10/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/03/2017
• Supplement Date Received by Manufacturer: 07/03/2017; 07/03/2017; 07/03/2017
• Initial Report FDA Received Date: 07/18/2017
• Supplement Report FDA Received Date: 08/14/2017; 08/23/2017; 09/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1