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

Model Number D134805

Device Problems Break (1069); Contamination /Decontamination Problem (2895)

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

Event Date 09/01/2022

Event Type  malfunction  

Event Description

It was reported that a patient underwent a ventricular tachycardia (vt) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and there was a broken tip and foreign material inside the pebax with external damage.During the procedure, at the end of the procedure, after several maneuverability's, mapping and ablation sessions with the ablation and mapping catheter when withdrawing it out of the patient's body it was clearly observed on the tip of the catheter that it is broken and blood was observed within this break.No patient consequence was reported.Additional information was received.There was no difficulty experienced while maneuvering the catheter or during the withdrawal.The event was assessed as mdr reportable for both the broken tip and foreign material inside the pebax with external damage.

Manufacturer Narrative

The event date is unknown.As a result, the 1st day of the month has been entered as the event date under b3.Date of event.A picture was received for evaluation following biosense webster's procedures.The picture investigation was completed on 28-sep-2022.According to pictures provided by the customer, the tip of the catheter was observed broken at the pebax section, blood was observed inside it.No other damages or anomalies were observed on it.Manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.The customer complaint was confirmed from the photo analysis.However, the device has not been returned for evaluation.Since no device has been received, no product investigation can be performed.If the device is received in the future, the product analysis will be performed as appropriate in order to find the root cause of the complaint.Explanation of codes: -investigation findings: appropriate term/code not available (c22)/ investigation conclusions: cause not established (d15) were selected as related to the analysis of the customer provided photo.-investigation findings: mechanical problem identified (c07)/ investigation conclusions: unintended use error caused or contributed to event (d1102)/ component code: tip (g04129) were selected as related to the customer¿s reported ¿broken tip¿ issue.-investigation findings: mechanical problem identified (c07) / investigation conclusions: unintended use error caused or contributed to event (d1102)/ component code: sleeve (g04115) were selected as related to the customer¿s reported ¿foreign material inside the pebax - external damage¿ issue.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 bwi product analysis lab received the device for evaluation on 01-nov-2022.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.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

It was reported that a patient underwent a ventricular tachycardia (vt) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and there was a broken tip and foreign material inside the pebax with external damage.During the procedure, at the end of the procedure, after several maneuverability's, mapping and ablation sessions with the ablation and mapping catheter when withdrawing it out of the patient's body it was clearly observed on the tip of the catheter that it is broken and blood was observed within this break.No patient consequence was reported.The device evaluation was completed on 08-nov-2022.The device was returned to biosense webster (bwi) for evaluation.A visual inspection and sem analysis of the returned device were performed in accordance with bwi procedures.Visual analysis revealed reddish material inside the pebax.A sem (scanning electron microscope) study was performed.Mechanical damage and a hole was observed on the pebax surface.This condition may be related to the broken tip issue described by the customer; however, the root cause of the damage on the pebax could not be conclusively determined, but it was concluded that it occurred outside the bwi manufacturing facilities.A manufacturing record evaluation was performed for the finished device 30856926l, and no internal actions was found during the review.The broken tip and foreign material inside the pebax issues reported by the customer were confirmed.It should be noted that product failure is multifactorial.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.This product issue will be addressed through bwi's quality system.Initially the lot number was unknown.However, during the investigation analysis, the lot number was retrieved.Therefore, processed d4.Lot, d4.Expiration date and h 4.Device manufacture date.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: pc-001194001 the picture investigation was reopened and completed on 02-dec-2022 to correct the coding submitted in the 3500a initial.Removed in h6.Component code field "tip (g04129)" and in h6.Investigation conclusions field remove "unintended use error caused or contributed to event (d1102)".Therefore, h10.Additional manufacturer narrative should have stated: explanation of codes: -investigation findings: appropriate term/code not available (c22)/ investigation conclusions: cause not established (d15) were selected as related to the analysis of the customer provided photo.-investigation findings: mechanical problem identified (c07)/ investigation conclusions: cause not established (d15) / component code: sleeve (g04115) were selected as related to the customer¿s reported ¿broken tip¿ issue and ¿foreign material inside the pebax - external damage¿ issue.

• Brand Name: THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez ; MX
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15525920
• MDR Text Key: 306427738
• Report Number: 2029046-2022-02362
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30856926L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1