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

Model Number D134805

Device Problems Coagulation in Device or Device Ingredient (1096); Device Contamination with Body Fluid (2317)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/22/2020

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.Biosense webster manufacturer's reference number (b)(4) has two complaints that are related to the same incident.Manufacturer's ref.No: (b)(4).

Event Description

It was reported that during an ablation procedure the cavotricuspid ishmus (cti) was ablated, and thrombus was found adhered to the tip of the thermocool® smart touch® sf bi-directional navigation catheter (lot# 30280027m) when it was removed from the sheath.The catheter was replaced with a new thermocool® smart touch® sf bi-directional navigation catheter (lot # 30276828m) and the procedure was successfully completed.At the end of the procedure, when the replacement catheter was removed from the patient¿s body, thrombus was found attached to the tip.There was no patient consequence reported.No error messages were observed on any biosense webster, inc.Equipment.The physician confirmed the patient did not exhibit any neurological symptom since the procedure was completed.

Manufacturer Narrative

The biosense webster, inc.Product analysis lab received the device for evaluation and noted on february 15, 2020 that there was red-brownish material on the dome.Since the event description reported that thrombus was found adhered to the tip of the catheter when it was removed from the patient¿s body, the reddish-brown material observed by the biosense webster, inc.Product analysis lab was assessed as thrombus and remains reportable.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

Investigation summary: it was reported that during an ablation procedure the cavotricuspid ishmus (cti) was ablated, and thrombus was found adhered to the tip of the thermocool® smart touch® sf bi-directional navigation catheter (lot# 30280027m) when it was removed from the sheath.The catheter was replaced with a new thermocool® smart touch® sf bi-directional navigation catheter (lot # 30276828m) and the procedure was successfully completed.The device was visually inspected and a red-brownish material was observed on the dome.A closer second inspection was performed and thrombus was identified as the material on the dome.An electrical test was performed on the catheter and it was found within specifications.No electrical malfunction was observed.Additionally, the catheter was tested on the generator and the temperature and impedance values were observed within specifications.Then, a cool flow pump test was performed, and it was found within specifications.The catheter was irrigating correctly.No irrigation issues were observed.A manufacturing record evaluation was performed and no internal action related to the complaint was found during the review.The customer complaint was confirmed.The root cause of the thrombus reported by the customer could be related to the usage of the device during the procedure; however, this cannot be conclusively determined.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).

Manufacturer Narrative

Manufacturer's reference number: (b)(4) initially this event was assessed as mdr reportable for a thrombus issue.During review on(b)(6) 2021, a correction was noted to the assessment as this event should have been assessed as char which is not mdr reportable.Char is a physical phenomenon of radio frequency energy delivery and can be the normal result of the ablation process.The presence of char on the electrodes does not represent a serious injury in itself, nor is it necessarily the result of device malfunction.Therefore, updated under ¿h6.Medical device problem code¿ from ¿coagulation in device or device ingredient¿ to ¿device contamination with body fluid¿.

• 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: 9712701
• MDR Text Key: 191704532
• Report Number: 2029046-2020-00244
• 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
• Report Date: 01/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/27/2020
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30280027M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2020
• Date Manufacturer Received: 05/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: THMCL SMTCH SF BID, TC, D-F.; UNKNOWN BRAND SHEATH.; UNK_SMARTABLATE GENERATOR.