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

Model Number D134805

Device Problems Coagulation in Device or Device Ingredient (1096); Material Puncture/Hole (1504); Device Contamination with Body Fluid (2317)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/20/2020

Event Type  malfunction  

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer¿s ref # (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure and a thrombus issue occurred.It was reported that during the ablation procedure, a thrombus was confirmed attached to the tip electrode of the a thermocool® smart touch® sf bi-directional navigation catheter.The issue was resolved by changing the catheter to another one.The procedure was completed without patient consequences.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.Should more information become available, it will be reviewed and processed accordingly.

Manufacturer Narrative

It was reported that during the ablation procedure, a thrombus was confirmed attached to the tip electrode of the a thermocool® smart touch® sf bi-directional navigation catheter.The issue was resolved by changing the catheter to another one.The procedure was completed without patient consequences.On (b)(6) 2020, biosense webster inc.Received additional information indicating no error messages were observed on any equipment.The generator used was smartablate.Device evaluation details: on (b)(6) 2020, the complaint product was returned to biosense webster inc.¿s (bwi) product analysis lab (pal) for evaluation and the evaluation has now been completed.On(b)(6) 2020, the device was visually inspected, it was found slightly a bent on the dome, reddish material inside the pebax and a hole.These findings were reviewed and determined the issue of the hole in the pebax has been assessed as an mdr reportable malfunction since the integrity of the device is compromised.The root cause of bent on the dome, cannot be determined.Unit was inspected prior leaving the facility as there are functional tests and inspections at control points based on the process flow diagram of this device per its part number that indicates a proper manufacturing in accordance with documented specifications and procedures.The catheter was tested on the generator and the temperature, impedance values, cool flow pump test, were observed within specifications.The catheter was irrigating correctly, no irrigation issues were observed.A manufacturing record evaluation was performed and no internal action was found during the review.Unit was inspected prior leaving the facility as there are functional tests and inspections at control points based on the process flow diagram of this device per its part number that indicates a proper manufacturing in accordance with documented specifications and procedures.The catheter passed all specifications.The customer complaint cannot be confirmed since the device was found working correctly and no evidence of thrombus was observed on the catheter, however, the root cause of the thrombus reported by the customer could be related to the usage of the device during the procedure.The root cause of the damage on the pebax cannot be related to the manufacturing process since there is evidence that the device was manufactured in accordance with documented specification and procedures, it could be related to the handling 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 ref.# (b)(4).

Manufacturer Narrative

The product investigation was re-open to include details to clarify that ¿no evidence of char was observed on the catheter¿ during visual analysis/inspection of the device.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4) initially this event was assessed as mdr reportable for a thrombus issue.During review on 5/20/2021, 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, the h6.Medical device problem code has been updated from ¿coagulation in device or device ingredient¿ to ¿device contamination with body fluid¿ to better represent the issue.This event is no longer considered to be mdr reportable for the thrombus/clot issue but remains mdr reportable for the reported issue of ¿hole in the pebax¿.The appropriate h6.Medical device problem code for this finding is ¿material puncture/hole (a041001).¿.

• 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: 10422546
• MDR Text Key: 205682819
• Report Number: 2029046-2020-01059
• 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
• Report Date: 07/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/12/2021
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30376697M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2020
• Date Manufacturer Received: 05/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SMARTABLATE GEN. KIT (JAPAN); THMCL SMTCH SF BID, TC, D-F