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

Model Number D134805

Device Problems Material Separation (1562); Positioning Problem (3009)

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

Event Date 01/01/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone: (b)(6).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: pc-(b)(4).

Event Description

It was reported that an unknown patient underwent an unknown ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.During the procedure the catheter shaft was broken.The physician could not get any curve on the catheter it was replaced with a new one.The procedure was successfully completed.The catheter was removed easily without additional intervention.No patient consequence.The damage did not result in wires being exposed or in any lifted or sharp rings.There was no resistance or difficulty during insertion or removal of the catheter.There was no visual damage on the catheter.Bi-directional curve mechanism stopped working while the case.The catheter was not pre-shaped.The deflection issue is not mdr-reportable.The broken shaft is mdr-reportable.

Manufacturer Narrative

On (b)(6) 2021, additional information was received indicating that there were no fragments generated from the device breakage.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

The product investigation was completed as the complaint device was not returned.Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.A device history record was performed for the finished device 30373291l 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).

Manufacturer Narrative

On 10-jul-2021, the bwi product 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.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

On 27-jul-2021, the product investigation was completed.It was reported that an unknown patient underwent an unknown ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.During the procedure the catheter shaft was broken.The physician could not get any curve on the catheter it was replaced with a new one.The procedure was successfully completed.The catheter was removed easily without additional intervention.No patient consequence.Device evaluation details: the product was returned to biosense webster for evaluation.Bwi conducted a visual inspection and a deflection test of the returned device.Visual analysis of the returned sample revealed that no damage or anomalies were observed on the smarttouch sf (bidirectional) catheter.Deflection test was performed.In accordance with bwi procedures, the catheter failed the test since it was only partially deflecting.Therefore, the catheter was dissected from from tip.It was determined that the t-bar was slid down from its place, causing the improper deflection condition.The issue related the shaft of the catheter could not be confirmed.However, the issues related to the curve of the catheter can be confirmed due to the t-bar conditions.A device history record was performed for the finished device 30373291l 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: THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 11610457
• MDR Text Key: 266390016
• Report Number: 2029046-2021-00496
• 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,Followup,Followup,Followup,Followup
• Report Date: 05/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/06/2021
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30373291L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2021
• Date Manufacturer Received: 07/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PREFACE LONG SHEATH.