MAUDE Adverse Event Report: BIOSENSE WEBSTER INC SMARTABLATE¿ IRRIGATION TUBING SET; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number SAT001

Device Problem Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/26/2022

Event Type  malfunction  

Event Description

It was reported that a patient underwent a right atrial tachycardia (right-at) ablation procedure with a smartablate¿ irrigation tubing set and the tubing had a hole in it.The tubing had a hole and air was sucked in.No harm to the patient occurred.The surgery was delayed 3 minutes due to the reported event.Action taken when event occurred was to use new tubing.The procedure was successfully completed.No fragments were generated.There was no patient consequence.No other medical intervention was required.The issue occurred during use and not during flushing.The customer flushed the tubing before using it on the patient.The tubing problem was assessed as a mdr reportable product malfunction.

Manufacturer Narrative

Initial reporter address line 1 (cont.): (b)(6), 1.Initial reporter phone: (b)(6).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

It was reported that a patient underwent a right atrial tachycardia (right-at) ablation procedure with a smartablate¿ irrigation tubing set and the tubing had a hole in it.The tubing had a hole and air was sucked in.No harm to the patient occurred.The surgery was delayed 3 minutes due to the reported event.Action taken when event occurred was to use new tubing.The procedure was successfully completed.No fragments were generated.There was no patient consequence.No other medical intervention was required.The issue occurred during use and not during flushing.The customer flushed the tubing before using it on the patient.The biosense webster (bwi) product analysis lab received the device for evaluation on (b)(6) 2023.A visual inspection and irrigation test of the returned device was performed following bwi procedures.Visual inspection revealed no anomalies on the device; however, during the irrigation test, leakage was observed in the transition joint of the drip chamber and the irrigation tube.A microscopic inspection of the joint was performed, and adhesive residues were detected that confirmed a good manufacturing assembly process.Device history record was performed for the finished device ac7256425 number, and no internal action related to the complaint was found during the review.The issue reported by the customer was confirmed.The root cause of the leakage detected in the transition joint could be related to the excessive force or manipulation of the device during the procedure; however, this cannot be conclusively determined.It should be noted that product failure is multifactorial.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.This product issue will be addressed through bwi¿s quality system.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device ac7256425 number, and no internal action related to the complaint was found during the review.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

• Brand Name: SMARTABLATE¿ IRRIGATION TUBING SET
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): LAKE REGION MEDICAL; 31-c butterfield trail; el paso TX 79906 0000
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 15853948
• MDR Text Key: 307777139
• Report Number: 2029046-2022-02934
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009743
• UDI-Public: 10846835009743
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P990017/S17
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/22/2023

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: 04/30/2023
• Device Model Number: SAT001
• Device Catalogue Number: SAT001
• Device Lot Number: AC7256425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/26/2022
• Initial Date FDA Received: 11/23/2022
• Supplement Dates Manufacturer Received: 04/14/2023; 07/25/2023
• Supplement Dates FDA Received: 05/11/2023; 08/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2022
• 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
• Treatment: UNK_SMARTABLATE PUMP TUBING