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

Model Number D-1336-01-S

Device Problems Break (1069); Sticking (1597)

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

Event Date 07/15/2015

Event Type  malfunction  

Manufacturer Narrative

Since the lot number is unknown, the full udi number can not be provided.(b)(4).

Event Description

It was reported that a patient underwent an ischemic ventricular tachycardia (isvt) procedure with a smart touch unidirectional catheter.During the procedure, the tip of the catheter was physically broken between the distal and proximal electrode and it seems to have gotten caught in the chordae tendineae of the mitral valve.The sheath used was agilis (st.Jude medical) with 8 french inner diameter.They had difficulty removing the catheter.No surgical intervention was needed.After long manipulation, the catheter was removed from the patient.A piece of the endocardium was seen on the catheter tip.The deflection was stuck in a partially deflected position.The procedure was completed with no patient consequence.There was no evidence that the patient had any symptoms of cardiac valve insufficiency.The deflection stuck in a partially deflected position was assessed as not reportable.The potential risk that it could cause or contribute to a serious injury or death is remote.Since they reported physical damage observed between the electrodes on the catheter tip, this issue has been assessed as reportable.Also, since there was foreign material reported within the usable length of the catheter and to be conservative, this issue has been assessed as reportable.

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation on 8/25/15.During the first visual inspection, the damages that reported in the initial report have been observed.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)(4).

Manufacturer Narrative

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.Device history record (dhr) review cannot be conducted because no lot number was provided by the customer.(b)(4): no testing methods performed.No results available since no evaluation performed.Device not returned.(b)(4).

Manufacturer Narrative

During an internal review of this complaint on february 25, 2016, it was found that during the biosense webster analysis the lot number was retrieved from the catheter.The lot number is 17218034m.Therefore, the (b)(4).

Manufacturer Narrative

Notification was sent in the 3500a supplemental #3 stating that during an internal review of this complaint, it was found that during the biosense webster analysis the lot number was retrieved from the catheter.Therefore, the udi number was provided.Therefore, an internal corrective action has been opened to prevent this issue.(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.During the procedure, the tip of the catheter was physically broken between the distal and proximal electrode and it seems to have gotten caught in the chordae tendineae of the mitral valve.The sheath used was agilis (st.Jude medical) with 8 french inner diameter.They had difficulty removing the catheter.No surgical intervention was needed.After long manipulation, the catheter was removed from the patient.A piece of the endocardium was seen on the catheter tip.The deflection was stuck in a partially deflected position.The procedure was completed with no patient consequence.There was no evidence that the patient had any symptoms of cardiac valve insufficiency.The returned device was visually inspected upon receipt and pebax was found deformed with reddish brown material on the inside.No biological material was found outside of the pebax.The physical damage observed at the pebax area could only be reproduced by applying a sufficient external force to permanently yield the material.It is concluded that the pebax sleeve may have been deformed during the procedure or during the removal process.Additionally, a deflection test was performed and catheter passed.It was not stuck in a deflected position.It remains unknown how the catheter got stuck inside the mitral valve.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 reported customer complaint has been verified.However, it remains unknown how the catheter got stuck in the mitral valve and how the pebax was deformed.

• 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: 5000974
• MDR Text Key: 24793269
• Report Number: 9673241-2015-00520
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: HU
• 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,Followup,Followup
• Report Date: 07/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2016
• Device Model Number: D-1336-01-S
• Device Catalogue Number: D133601
• Device Lot Number: UNK_D-1336-01-S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/15/2015
• 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