MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THMCL SMTCH SF BID, TC, D-F; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number D134805

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/24/2019

Event Type  malfunction  

Manufacturer Narrative

The biosense webster inc.(bwi) product analysis lab (pal) received the device for evaluation on 7/17/2019.Upon initial inspection, no visual damage or anomalies observed.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.No code available was used in h6 section to represent the procedure delay.Manufacture reference no: (b)(4).

Event Description

It was reported that a (b)(6) female patient underwent an ablation procedure for atrial tachycardia (at) with a thermocool® smart touch® sf bi-directional navigation catheter, and a high risk procedure delay issue occurred.It was reported at the time of application, the catheter presented a failure in the temperature sensor.The connection was changed, but the error code ¿change catheter¿ persisted.The connection was changed again, and the issue continued.Catheter replacement resolved the issue and the procedure was completed.However, the procedure was delayed 40 minutes.The physician indicated the procedure delay contributed to anesthesia and lengthened procedure.The user was trained, and the rep was present during the event.No adverse patient consequences were reported.The observed no temperature issue has been assessed as not mdr reportable.The potential that it could cause or contribute to a death, serious injury, or other significant adverse event, is remote.The high risk procedure delay has been assessed as mdr reportable.

Manufacturer Narrative

It was reported that a 55-year-old female patient underwent an ablation procedure for atrial tachycardia (at) with a thermocool® smart touch® sf bi-directional navigation catheter, and a high risk procedure delay issue occurred.It was reported at the time of application, the catheter presented a failure in the temperature sensor.The investigational analysis completed 8/28/2019.Upon receipt, the catheter was visually inspected and it was found in normal conditions.The returned device was then evaluated for electrical resistance and the thermocouple test failed.Further examination revealed that the thermocouple wires were broken at the tip section creating an intermittence of temperature.A manufacturing record evaluation was performed and no internal actions were identified.The customer complaint was confirmed.This issue does not represent any patient safety impact since the device is unable to deliver radio frequency energy to ablate.Manufacture reference no: (b)(4).

• Brand Name: THMCL SMTCH SF BID, TC, D-F
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 8805196
• MDR Text Key: 153110689
• Report Number: 2029046-2019-03443
• 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
• Report Date: 06/25/2019

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: 07/18/2019
• Device Catalogue Number: D134805
• Device Lot Number: 30083771L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2019
• Initial Date Manufacturer Received: 06/25/2019
• Initial Date FDA Received: 07/18/2019
• Supplement Dates Manufacturer Received: 08/05/2019
• Supplement Dates FDA Received: 09/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 52