MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) THERMOCOOL® SMARTTOUCH® SF UNI-DIRECTIONAL NAV CATHETER; SIMILAR DEVICE D133601, PMA # P030031/S053

Model Number D-1347-02-S

Device Problems Charred (1086); Peeled/Delaminated (1454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/03/2015

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.The ¿suspected medical device¿ reported in section d of this report is not marketed in usa or approved by the fda.However, it is being reported as biosense webster considers this as a similar device to thermocool smart touch electrophysiology catheter approved under (b)(4).(b)(4).Event description continuation: consequence.Also, after the catheter was extracted, the physician put the tip into the saline solution.After this, he put the catheter on white tissue which could be seen on the pictures that he had provided to observe the catheter.It was stated that there was no catheter damage.The physician was very careful.It was stated that this observation could have been a fiber of the white tissue used after the procedure.The char was assessed as not reportable as char is a physical phenomenon of radiofrequency and can be the normal result of an ablation process.The presence of char on the electrodes does not represent a serious injury in itself nor is necessarily the result of device malfunction.Per the additional information received stating there was no catheter damage and that what was being seen was a fiber of the tissue used after the procedure, this issue was also assessed as not reportable.The bwi failure analysis lab noted on july 27, 2015 the returned catheter condition on the proximal side of electrode ring #1.The polyurethane (pu) margin was peeling back from one area and from the other area the pu was lifted up.Also, char was seen on the distal end of tip dome.After the decontamination process, the tip dome was found dented.The tip dome dented was assessed as not reportable.No sharp edges were observed.If this issue occurred during the procedure, most likely consequence would be an intraprocedural delay.The potential risk that it could cause or contribute to a serious injury or death would be remote.Also, during the first visual inspection at the bwi failure analysis lab, this issue was not noted.The issue was noted after decontamination.Therefore, this issue could have occurred during handling of the product after the first visual inspection.Originally a picture had been provided of the reported char issue and clarification was requested as there was something clear at the side of the tip of the catheter that was sticking out.The clarification received stated there was no catheter damage and what was being seen was a fiber of the tissue used after the procedure.Therefore, with the information available at that time, this issue was assessed as not reportable.The biosense webster failure analysis lab received the catheter on july 27, 2015 and noted that the pu margin was peeling back from one area and from the other area, the pu was lifted up.Since this issue had a probability that it could be broken off or detached, this finding was assessed as reportable.The awareness date is july 27, 2015.

Event Description

It was reported that a patient underwent a pulmonary vein isolation (pvi) procedure with a smart touch unidirectional sf catheter and a the biosense webster failure analysis lab noted the returned catheter condition that on the proximal side of electrode ring #1 as the polyurethane (pu) margin was peeling back from one area and from the other area the pu was lifted up.After the successful procedure (ablation for pvi), charring was observed by the physician on the tip of catheter.There were no issues related to the temperature and flow on the catheter.The settings were: ablation power: 30w force parameters; 10g-40g, max force observed 50g; application time:120sec, force range: 12g-25g most of the case; impedance: 150ohm; visitag parameters: 15sec, 15frc as filter; radiation 5mins; total mapping time:50min; total case from skin to skin 2:30mins.They were using saline solution with anticoagulant (heparin).The act was maintained at 190-250-300 and was checked every 20mins.The physician did not consider the amount of char observed caused a potential risk to this patient.He did an echo at the end of procedure to ensure that everything was fine.There was no patient consequence.A follow-up was performed on the patient's current condition and for clarification as the picture that was provided reflected that there was something clear at the side of the tip of the catheter that seemed to be sticking out.Additional information was provided.The patient did not exhibit any neurological symptoms since the procedure completion and there was no patient.

Manufacturer Narrative

(b)(4).It was reported that a patient underwent a pulmonary vein isolation (pvi) procedure with a smart touch unidirectional sf catheter.After the successful procedure (ablation for pvi), charring was observed by the physician on the tip of catheter.There were no issues related to the temperature and flow on the catheter.There was no patient consequence.Upon receipt, the catheter was visually inspected and polyurethane (pu) margins were found peeled on proximal side of ring # 1 and the pebax.After decontamination, the tip dome was found dented.Due to these conditions a scanning electron microscope (sem) testing was performed over the area to identify the root cause of the pu damage.Sem results showed that there was evidence in the pu area of damage by a sharp point object and dome presented evidence of abrasion marks.Char with reddish brown material was also observed on the distal end of tip dome during the visual inspection.Per this condition and issue reported, the catheter was tested for electrical performance, temperature response and stockert compatibility and it was found within specifications.Then an irrigation test was performed and the catheter failed.Further examination revealed that irrigation tubing was filled with red brown material as well as it was slightly bent at the piston area.Further investigation was performed on the irrigation tube and it was not possible to deduce whether the assumed blood material present in the fluid lumen lead to or contributed to the exterior char owing to the lack of temporal data.Furthermore, due to the lack of any irrigation or temperature related issues during the procedure, post-procedure handling or irrigation tubing disconnection during non-ablation operating conditions cannot be ruled out as the source of the presumed blood material present in the fluid lumen.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.The customer complaint regarding char on catheter has been verified.

• Brand Name: THERMOCOOL® SMARTTOUCH® SF UNI-DIRECTIONAL NAV CATHETER
• Type of Device: SIMILAR DEVICE D133601, PMA # P030031/S053
• 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: shahe garabedian ; 9098397362
• MDR Report Key: 5029996
• MDR Text Key: 25502483
• Report Number: 9673241-2015-00558
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 06/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2015
• 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-1347-02-S
• Device Catalogue Number: D134702
• Device Lot Number: 17125723L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2014
• 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