MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D134805

Device Problems Break (1069); High Readings (2459)

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

Event Date 06/16/2021

Event Type  malfunction  

Event Description

A patient underwent an ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter for which biosense webster¿s product analysis lab identified a broken pebax with some internal components of the tip exposed.There was reddish material found inside.The finding was identified on (b)(6) 2021.It was initially reported by the customer that when ablation was conducted, the contact force was abnormally high.The issue was resolved by changing the smart touch sf catheter to another one.The procedure was completed without patient's consequence.The force issue is not mdr-reportable.The broken pebax and exposed internal parts are mdr-reportable.

Manufacturer Narrative

(b)(6).The product investigation was completed.Device evaluation details: visual analysis of the returned sample revealed reddish material and a hole in the pebax, internal parts are exposed.The force sensor test was performed, in accordance with bwi procedures.No errors were found during the test.The force issue was unable to duplicate during the product investigation however, the blood inside the pebax could cause the force sensor issue.The root cause of the pebax damage cannot be related to the manufacturing process since there is evidence that the device was manufactured in accordance with documented specifications and procedures.It could be related to the handling of the device during the procedure; however, this cannot be conclusively determined.A manufacturing record evaluation was performed for the finished device 30523449m number, and no internal action related to the complaint was found during the review.Regarding the visual finding observed, the instruction for use contains the following information: in order to prevent damage to the catheter tip, use the insertion tube supplied with the catheter to advance or retract the catheter through the hemostasis valve of the sheath.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.(b)(4).

• Brand Name: THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• MDR Report Key: 12565657
• MDR Text Key: 281086346
• Report Number: 2029046-2021-01615
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 09/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/12/2022
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30523449M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2021
• Date Manufacturer Received: 09/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1