MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL SMART TOUCH ELECTROPHYSIOLOGY CATHETER; SIMILAR DEVICE D133601, PMA # P030031/S053

Catalog Number D133604IL

Device Problems Break (1069); Incorrect, Inadequate or Imprecise Result or Readings (1535); High Readings (2459)

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

Event Date 03/25/2021

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 ref.# (b)(4).

Event Description

It was reported that a patient underwent a cardiac ablation procedure with a thermocool® smart touch¿ electrophysiology catheter wherein a gap was found in tip of the catheter near the pebax.It was reported that the catheter was used to map for 50 minutes (aortic retrograde, force 30-40g, ventricular premature beat).When it was used to ablate, force sensor error was reported, and force high.Zero calibration was failed.Physician removed the catheter and found the gap in the tip near the pebax.The physician he switched another new catheter to complete the operation.There was no patient consequence reported.The sheath used together is cordis 8f short sheath.The customer¿s reported high force and force sensor errors are not considered to be mdr reportable since the issues are highly detectable when occurring and the potential risk that it could cause or contribute to a serious injury or death to the operator or patient is remote.

Manufacturer Narrative

It was reported that the catheter was used to map for 50 minutes (aortic retrograde, force 30-40g, ventricular premature beat).When it was used to ablate, force sensor error was reported, and force high.Zero calibration was failed.Physician removed the catheter and found the gap in the tip near the pebax.The physician he switched another new catheter to complete the operation.There was no patient consequence reported.The sheath used together is cordis 8f short sheath.Device evaluation details: the product was returned to biosense webster inc.(bwi) for evaluation and the evaluation has been completed.Bwi conducted a visual inspection and a carto 3 evaluation of the returned device.Visual analysis of the returned sample revealed that no damage or anomalies were observed on the device.Force sensor functionality was tested on carto and the catheter failed, error 106 was observed.A failure analysis was performed, the catheter was dissected and the sensor values were found within specifications.With this information, the failure can be attributed to a potential pc board failure.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.As part of bwi¿s quality process all devices are manufactured, inspected, and released to approved specifications.It should be noted that product failure is multifactorial.The instructions for use (ifu) contain the following warning stated in the carto 3 system manual, which was performed for this product: if error 106 is observed, replace the catheter cable or the catheter.Complaint regarding a force issue was confirmed.Complaint regarding the "gap in tip near the pebax", it could not be confirmed during failure analysis of the returned device since the device was observed in normal conditions and no anomalies were observed.In addition, the customer had provided a videos to help aid in the investigation.The videos show "hi" error was observed on carto 3 screen.In addition, the helix component in the tip was observed broken.The force issues reported could be related to the damage observed in the tip.The customer complaint was confirmed based on the videos received.Explanation of codes: investigation findings: no device problem found (c19) / investigation conclusions: no problem detected (d14) were selected as related to the gap near pebax.Investigation findings: incompatible component/accessory (c0402) / investigation conclusions: cause traced to component failure (d02) / component code: circuit board (g02005) 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

On (b)(6)2021, the bwi product analysis lab received the complaint device for evaluation.The product 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 ref.#(b)(4).

• Brand Name: THERMOCOOL SMART TOUCH ELECTROPHYSIOLOGY CATHETER
• Type of Device: SIMILAR DEVICE D133601, PMA # P030031/S053
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 11699915
• MDR Text Key: 246553241
• Report Number: 2029046-2021-00618
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• 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: 04/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/21/2022
• Device Catalogue Number: D133604IL
• Device Lot Number: 30491353M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2021
• Date Manufacturer Received: 05/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CORDIS 8F SHORT SHEATH; THMCL SMARTTOUCH,TC,D,C3,OBL; CORDIS 8F SHORT SHEATH; THMCL SMARTTOUCH,TC,D,C3,OBL