MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) THERMOCOOL® SMARTTOUCH® SF BI-DIRECTIONAL NAV CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D-1348-05-S

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

Patient Problem Thrombus (2101)

Event Date 01/25/2017

Event Type  malfunction  

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation.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.(b)(6).Manufacturer's ref.No: (b)(4).

Event Description

It was reported that a patient underwent an ablation procedure with a thermocool® smarttouch® sf bi-directional nav catheter and a signal loss occurred.After three hours of ablation, there were no signals of the catheter on the carto 3 system or the recording system.The connections were checked and then the cables were changed and the issue remained.The ep shuttle program was also checked but there was still no resolution.After changing the catheter, the issue resolved.The procedure was continued and completed with no patient consequence.This event was originally assessed as not mdr reportable since the signal loss was only affecting the intracardiac electrograms, the patient's heart rhythm is still visible to the operator therefore the risk to the patient is low.The catheter was returned to the biosense webster failure analysis lab and on (b)(6) 2017, it was discovered that the catheter had a bump and reddish material was seen in the pebax area.The presence of reddish material is an expected finding after these procedures.In addition, the bump is not reportable since there is no exposure of internal components, or any evidence that the integrity of the catheter has been compromised.The potential that this issue could cause or contribute to a death, serious injury, or other significant adverse event is remote.During further analysis, on (b)(6) 2017, it was discovered that there was exposed wire between the dome and ring# 1.During the procedure, there was no difficulty during withdrawal of the catheter through the st.Jude agilis 9 french sheath.This issue was not seen prior to use, upon withdrawal or prior to sending the catheter back for analysis.If internal parts are exposed, the risk to the patient is critical due to the potential of thrombus formation from exposure of internal parts of the catheter, therefore this finding is mdr reportable.The awareness date has been reset to (b)(6) 2017, the date the reportable finding was discovered.

Manufacturer Narrative

Manufacturer's ref.No: (b)(4).It was reported that a patient underwent an ablation procedure with a thermocool® smarttouch® sf bi-directional nav catheter and a signal loss occurred.The returned device was visually inspected and it was found an exposed wire between dome and ring # 1 (which is why this complaint is mdr reportable) and reddish material was observed inside the pebax.Then, the returned device was evaluated for electrical resistance and current leakage and it failed on electrode # 2 since the exposed wire was observed.Per the condition observed, a scanning electron microscope (sem) testing was performed and the results showed evidence of a hole on the surface of the pebax, it is possible that damage was generated with an unknown object.No evidence of damage at the area around the exposed wire was observed.No other anomalies were observed.Additionally, another sem was performed to identify the damage around the exposed wire and it showed evidence of damage at the transition between dome and the pebax just at the edge of dome.For the condition found, a manufacturing meeting was held to investigate this condition and the result was that this is not a manufacturing related issue, since there is evidence that the catheter was manufactured in accordance with documented specification and procedures and the failure could not be duplicated.Furthermore, it was observed that the polyurethane was applied correctly and the ring was separate from the tip.In addition, evidence was found that the wire was welded to the ring.Awareness training was provided to the production associates to be aware of this kind of issue.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 has been confirmed.Based on available analysis finding results, the failure mode does not appear to be caused by any internal bwi processes since the device was manufactured in accordance with documented specification and procedures.

• Brand Name: THERMOCOOL® SMARTTOUCH® SF BI-DIRECTIONAL NAV CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua 32599 ; MX 32599
• Manufacturer (Section G): BIOSENSE WEBSTER, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua 32599 ; MX 32599
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 6818482
• MDR Text Key: 83738613
• Report Number: 9673241-2017-00672
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: (01)10846835010183(11)161025(17)170930(10)17584796L
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/10/2017

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: 09/30/2017
• Device Model Number: D-1348-05-S
• Device Catalogue Number: D134805
• Device Lot Number: 17584796L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/09/2017
• Initial Date FDA Received: 08/24/2017
• Supplement Dates Manufacturer Received: 02/09/2017
• Supplement Dates FDA Received: 10/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2016
• 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