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

Model Number D-1336-02-S

Device Problems Break (1069); Scratched Material (3020); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/29/2015

Event Type  malfunction  

Manufacturer Narrative

No device was received for analysis at the time of submission of the initial 3500a.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.Methods: no testing methods performed.Results: no results available since no evaluation performed.Conclusion: device not returned.The device history record (dhr) was reviewed.In addition, the dhr review verifies that the devices were manufactured in accordance with documented specification and procedures.(b)(4).

Event Description

It was reported that a patient underwent an ischemic ventricular tachycardia (isvt) procedure with a smart touch unidirectional catheter.The outer layer of the catheter got damaged due to a lot of movement of the catheter in the sheath.There were scratches in the outer layer on different parts of the catheter both proximal and distal.There were no wires exposed.An 8f sheath was used.Later, there was noise on the catheter signal.The procedure was completed with no patient consequence.Since the noise was only reported on the catheter's signal, the risk to the patient is low.Therefore, this issue was assessed as not reportable.The physical damage to the catheter is being conservatively assessed as reportable.A picture was requested.However, it was not provided and the product has not been received.Therefore, since the damage was described as part of the catheter that would be in the patient and the severity of the damage is not known, it was conservatively assessed as reportable.

Manufacturer Narrative

In the 3500a it was reported that the physical damage to the catheter was conservatively assessed as reportable since the damage was described as part of the catheter that would be in the patient and the severity of the damage was not known.However, the bwi failure analysis lab received the device for evaluation on 9/9/15.The returned catheter condition reflects braid wires exposed on the shaft and foreign fibers.The integrity of the catheter has been compromised.This issue has been assessed as a reportable malfunction.The analysis has begun but is not completed at this time.Therefore, the foreign fibers are being conservatively reported as they were found in the usable length of the catheter.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.(b)(4).

Manufacturer Narrative

(b)(4).It was reported that a patient underwent an ischemic ventricular tachycardia (isvt) procedure with a smart touch unidirectional catheter.The outer layer of the catheter got damaged due to a lot of movement of the catheter in the sheath.There were scratches in the outer layer on different parts of the catheter both proximal and distal.There were no wires exposed.An 8f sheath was used.Later, there was noise on the catheter signal.The procedure was completed with no patient consequence.Upon receipt, the device was visually inspected and the shaft was found damaged and twisted causing the catheter to be broken and with braid exposed in some areas.The information received indicated that an 8f sheath was used during the procedure, this might have contributed to the shaft being damaged since the instructions for use (ifu) recommends using a 8.5 f sheath.Additionally, different analytical techniques as fourier transform infra red analysis (ft-ir), dcs and tg were carried out to determine if there were other external factors that could contribute to the shaft condition.However, it seems that sheath was the main contributor.An internal corrective action has been opened to investigate shaft damages.The returned device was evaluated for electrical resistance and thermocouple test and the catheter failed; current leakage was observed on all electrodes.Further examination revealed that catheter pcb was covered by corrosion causing the electrical malfunction.An irrigation test was performed however no leakage was observed.The catheter¿s shaft condition might have contributed to the device failure.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 has been verified.The root cause of the shaft might be due to the sheath usage.An internal corrective action has been opened to investigate shaft damages.

• Brand Name: THERMOCOOL® SMARTTOUCH® UNI-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 32599 ; MX 32599
• Manufacturer Contact: shahe garabedian ; 9098397362
• MDR Report Key: 5030361
• MDR Text Key: 25504440
• Report Number: 9673241-2015-00563
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P030031/S053
• 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: 07/29/2015

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: 09/30/2015
• Device Model Number: D-1336-02-S
• Device Catalogue Number: D133602
• Device Lot Number: 17107140M
• Other Device ID Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2014
• 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