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

Model Number D-1347-02-S

Device Problems Break (1069); Physical Resistance (2578)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/11/2017

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.Manufacturer's ref.No:(b)(4).

Event Description

It was reported that a patient underwent a ventricular outflow tract procedure with a smart touch unidirectional sf catheter.Originally it was reported that after 4 hours of working in the ventricle, they tried to pull the catheter back into the st.Jude medical 8.5fr sheath.However, this was only possible with some force.The catheter was checked and it was reported that they saw some damage on the electrode ring.They exchanged the catheter and the procedure was completed with no patient consequence.Additional clarification was requested and received on the reported electrode ring condition.No clarification could be provided on the condition of the electrode ring.There were no wires exposed on the catheter.The catheter was not pre-shaped.The resistance with the catheter and the sheath was assessed as not reportable as interference or friction between devices are a known occurrence.If resistance is encountered, the system may be withdrawn as a unit.This is a common practice during procedures.Since the vast majority of ep procedures utilize multiple device exchanges, an increased potential for patient injury is remote.Since the electrode ring issue was unclear, this issue was also assessed as not reportable as no patient risk could be identified.There was no patient consequence or intervention resulting from this device problem.The biosense webster failure analysis received the catheter for evaluation on june 2, 2017 and discovered that the pebax was cut with metal exposed.This issue with the pebax has been assessed as reportable as the risk to the patient could have been critical due to the potential of thrombus formation from exposure to internal parts of the catheter.Therefore, the awareness date for this pebax issue is reset to (b)(6) 2017.

Manufacturer Narrative

In the follow-up report #1, in error it was stated that the customer complaint was verified.It should have stated that the customer complaint cannot be confirmed since all the electrodes were found in normal conditions.Manufacturer's ref.No: (b)(4).

Manufacturer Narrative

Manufacturer's ref no: (b)(4).It was reported that a patient underwent a ventricular outflow tract procedure with a smart touch unidirectional sf catheter.After 4 hours of working in the ventricle, they tried to pull the catheter back into the st.Jude medical 8.5fr sheath.However, this was only possible with some force.The catheter was checked and it was reported that they saw some damage on the electrode ring.They exchanged the catheter and the procedure was completed with no patient consequence.Additional clarification was requested and received on the reported electrode ring condition.No clarification could be provided on the condition of the electrode ring.There were no wires exposed on the catheter.The catheter was not pre-shaped.The returned device was visually inspected and a cut was found on the pebax and metal was exposed.However, all electrodes were observed in normal conditions with no damage observed.The catheter outer diameter was measured and it was found within specification.Then for the condition observed a scanning electron microscope (sem) testing was performed and the results showed that is possible that damage was generated with an unknown object.No other anomalies were observed.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 the 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 verified.The root cause of damage cannot be determined.

• Brand Name: THERMOCOOL® SMARTTOUCH® SF UNI-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: 6673584
• MDR Text Key: 78911650
• Report Number: 9673241-2017-00525
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 1084683500978
• UDI-Public: (01)1084683500978(11)170127(17)171231(10)17623259L
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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,Followup
• Report Date: 04/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2017
• Device Model Number: D-1347-02-S
• Device Catalogue Number: D134702
• Device Lot Number: 17623259L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/11/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/27/2017
• 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