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

Catalog Number D134805

Device Problems Failure to Read Input Signal (1581); Physical Resistance (2578); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/19/2018

Event Type  malfunction  

Manufacturer Narrative

Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.As such, the investigation will be closed.If the complaint device is received in the future we will reopen the complaint and perform the investigation as appropriate.The device history record (dhr) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.Concomitant product: st.Jude medical sl1 sheath (model# unknown, lot# unknown).Manufacturer's ref.No: (b)(4).

Event Description

It was reported that a patient underwent a paroxysmal atrial fibrillation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and foreign material was found on the usable length of the catheter.During the procedure, the stsf catheter was re-inserted in the patient.After removing it, there was noise on the distal electrogram.The catheter was removed again from the sheath.The physician reported resistance this time, and pieces of the sheath were stuck in the catheter tip.The pieces were easily taken off by the scrub tech.There was no patient consequence.The electrogram signal noise is not reportable.Only the distal electrogram signals were affected by this issue.Therefore, the risk to the patient is low.Resistance is not a reportable issue.Interference or friction between devices is a known occurrence.If resistance is encountered, the system may be withdrawn as a unit.Increased potential for patient injury is remote.However, foreign material on the useable length of the catheter has been assessed as a reportable malfunction.

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation on 6/04/2018.The analysis has begun but is not completed at this time.It was discovered that white-colored unknown material was stuck on the catheter tip at approx 0.4 cm from distal tip.The composition of the foreign material is unknown at this time.Fourier transform infrared spectroscopy (ftir) analysis will be performed to determine the composition of the material observed.This coincides with the reported event.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.Manufacturer's ref.No: (b)(4).

Manufacturer Narrative

It was reported that a patient underwent a paroxysmal atrial fibrillation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and foreign material was found on the usable length of the catheter.The device was visually inspected and white colored unknown material was found stuck on the tip.Then, magnetic sensor functionality was tested on carto and the catheter was properly visualized and no errors were observed.Then, the force sensor feature was tested and it was working properly, the force values were observed within specifications.Then, deflection test was performed and it was found within specifications, the catheter was deflecting correctly.Then, electrical test was performed and the catheter failed, no electrical readings were observed on electrode # 2.A failure analysis was performed and the catheter was dissected on the tip area, the electrical wire was found broken causing the improper electrical signal.Also, the generator test was performed and the catheter passed the test.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 fourier transform infrared spectroscopy test (ftir) was performed and the results showed that foreign material is presumable composed or polyethylene with barium sulfate based material, this composite material is widely used as radio pacifier along medical device industries, it could be related to the preface used during the procedure.The device history record (dhr) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.During manufacturing process, all the catheters are inspected for visual damages before packaging.On line inspections and functional tests are in place to prevent this type of damage from leaving the facility.The customer complaint was confirmed.The root cause of the electrical breakage cannot be determined since there is evidence that the device was manufactured in accordance with documented specification and procedures.

• 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: 7508083
• MDR Text Key: 108148220
• Report Number: 2029046-2018-01539
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 04/19/2018

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: 12/06/2018
• Device Catalogue Number: D134805
• Device Lot Number: 17767034L
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/19/2018
• Initial Date FDA Received: 05/11/2018
• Supplement Dates Manufacturer Received: 04/19/2018; 04/19/2018
• Supplement Dates FDA Received: 06/27/2018; 07/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1