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

Model Number D-1233-01-S

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/25/2016

Event Type  malfunction  

Manufacturer Narrative

No device was received for analysis at the time of submission of the initial 3500a.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.(b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a coolflow tubing set.The package of the tubing set was not glued firmly as it was opened easily.They stated that they did not have enough information to judge if the sterility was compromised.They did not use the coolflow tubing set.The issue was resolved by changing the tubing set to another one.The procedure was completed without patient consequence.They described a possible packaging defect that may compromise the sterility of the product, which may expose the patient to the possibility of the introduction of micro-organisms into the vasculature and may result in the need for additional medical intervention or potentially may lead to permanent injury or impairment.Therefore, this issue has been assessed conservatively as a reportable malfunction.

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation on 6/7/2016.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).

Manufacturer Narrative

(b)(4).It was reported that a patient underwent an atrial fibrillation (afib) procedure with a coolflow tubing set.The package of the tubing set was not glued firmly as it was opened easily.They stated that they did not have enough information to judge if the sterility was compromised.They did not use the coolflow tubing set.The issue was resolved by changing the tubing set to another one.The procedure was completed without patient consequence.Upon visual inspection of pouch it appeared that the package had glue residue on the paper seal packaging that was sent back and had been pulled open and clear plastic was wrinkled.An irrigation test was performed and the tubing passed per specification.The tubing from the manufacture is thoroughly inspected according to the device history record (dhr).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.Based on available analysis finding results, the failure mode does not appear to be caused by any internal biosense webster, inc.Processes.

• Brand Name: COOLFLOW
• Type of Device: CATHETER, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER, INC. (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer (Section G): BIOSENSE WEBSTER, INC. (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 5681010
• MDR Text Key: 47224486
• Report Number: 2029046-2016-00051
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P990071/S5
• 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,Followup,Followup
• Report Date: 04/28/2016

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
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2017
• 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: 06/07/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/27/2016
• Initial Date FDA Received: 05/26/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 06/13/2016; 12/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/12/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1