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

Model Number D-1327-05-S

Device Problems Failure to Zero (1683); Material Integrity Problem (2978); Scratched Material (3020)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/25/2015

Event Type  malfunction  

Event Description

It was reported that a patient underwent a procedure with a smart touch bidirectional catheter and during the analysis of the catheter it was found that the pebax had an integrity issue.During the procedure, the signal of force was not indicated.Zero was made several times.The smart touch bidirectional catheter was not in close proximity to another catheter.The catheter was zeroed after the initial warm-up phase post catheter connection to the carto patient interface unit.The carto system indicated to re-zero the catheter.The issue occurred during ablation.The problem resolved after replacement of the catheter.The procedure was completed with no patient consequences.This reported issue is highly detectable and assessed as low risk to the patient.Therefore, assessed as not reportable.The bwi failure analysis lab received the device for evaluation on march 28, 2015 and during the initial inspection found that the clear sensor sleeve (pebax) had dried off white material inside with no holes or openings.The tip dome had reddish brown material on the proximal end.Light scratches on the tip dome.Additional clarification was requested on this returned catheter condition.It was confirmed that there was no patient consequence.The patient did not exhibit any neurological symptoms since the procedure was completed.This returned catheter condition was not noted prior to sending the catheter to the bwi failure analysis lab.The 8.5 fr sl0 sheath was used.

Manufacturer Narrative

(b)(4).Event description continuation: there was no damage to the pebax integrity that could cause the foreign material to travel into the patient¿s blood circulation.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, was remote.Therefore, this issue was assessed as not reportable.Char is a physical phenomenon of radio frequency and can be the normal result of an ablation process.The presence of char on the electrodes, do not represent a serious injury in itself nor is it necessarily the result of a device malfunction.Therefore, this issue was assessed as not reportable.As for the light scratches on tip dome, the integrity of the catheter was not compromised.Therefore, this issue was assessed as not reportable.This event is being reported because after further investigation noted on april 28, 2015 by the bwi failure analysis lab, the scanning electron microscope (sem) results showed that the pebax material located between the dome and electrode #2 presented rupture and evidence of scratches.Therefore, since the sem results showed that the pebax had an integrity issue, this issue has been assessed as reportable.The awareness date is reset to april 28, 2015.The returned device was visually inspected upon receipt and it was found that the clear sensor sleeve (pebax) had dried off white material inside.The tip dome had reddish brown material on the proximal end.It also had light scratches on the tip dome.A scanning electron microscope (sem) test was performed and it found clear evidence of mechanical damage on the dome material which resulted in scratches.Moreover, the pebax material located between the dome and electrode #2, presented rupture and evidence of scratches and abration marks.Considering that the pebax damaged section is aligned to the scratches caused on the dome, it is very likely that the unknown object which caused the mechanical damage on the dome, caused such damages on the pebax material as well.Additionally, sem/eds results showed that the whitish foreign matter analyzed presented elemental distribution of carbon, oxygen, sodium, sulfur, chlorine, potassium and calcium.The presence of chlorine and sodium could suggest that dry remains of the saline solution may have generated the foreign matter found on internal pebax surface.An internal corrective action has been opened to investigate the damaged pebax on smart touch.Further information received indicates that the visual findings were not noticed by the customer.The catheter was recognized by the carto 3 system, no error messages were displayed and the catheter was properly visualized.The catheter was then evaluated for screening test and force calibration check during a 1 minute of ablation and the force feature parameters failed.Further examination showed that the sensor was within specifications.According to the calibration results and the sensor readings, the improper condition was attributed to a potential pc board failure.The device history record was reviewed and no anomalies were found related to this complaint.The dhr review verifies that the device was manufactured in accordance with documented specification and procedures.The customer complaint has been verified.An internal corrective action has been opened to investigate the damaged pebax on smart touch.

• Brand Name: THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION 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 3259 9; MX 32599
• Manufacturer Contact: shahe garabedian ; 9098397362
• MDR Report Key: 4748103
• MDR Text Key: 21546674
• Report Number: 9673241-2015-00258
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/26/2015

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: 10/31/2015
• Device Model Number: D-1327-05-S
• Device Catalogue Number: D132705
• Device Lot Number: 17125546M
• Other Device ID Number: (01)10846835009200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/25/2015
• Initial Date FDA Received: 05/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1