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

Model Number D-1327-04-S

Device Problems Break (1069); Knotted (1340); Looping (1370)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/07/2015

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.(b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation procedure with a smart touch bidirectional catheter and the catheter became knotted on itself.The catheter prolapsed while being advanced into the right atrium and became knotted into a loop.Another ablation catheter was added and advanced into a long sheath and passed through the knot and then the smart touch catheter was pulled down into the inferior vena cava and the knot was undone.The procedure was continued and completed with no patient consequence.Upon request additional information was received on the event.The catheter had made a u-turn back on itself and it is assumed that it hit the sheath at an angle which caused it to push back upwards and around to create the knot.The knot was noticed on fluoroscopy as the physician could not advance the catheter so he stepped on fluoroscopy to confirm the catheter position.When the knot was initially noticed, the physician tried to pull back and twist on the catheter to free it but ultimately it moved the knot further proximal.Deflecting and relaxing the catheter tip was done distally to where the knot had occurred.There was difficulty in removing the catheter through the 8f short sheath.After the catheter was removed there was damage to the coating of the catheter, which was assumed to be a result of the knot getting undone with other catheters, sheaths and dilators.This event has been assessed as reportable because it could have potentially harmed the patient.

Manufacturer Narrative

(b)(4).It was reported that a patient underwent an atrial fibrillation procedure with a smart touch bidirectional catheter and the catheter became knotted on itself.Upon received it was reported that catheter has two broken areas found on the shaft approximately 11cm and 13cm from the tip.Braids are seen on both shaft bends.Additional information was received on the event that stated that the physician had difficulty in removing the catheter.The customer reported that the catheter had made a u-turn back on itself, and it hit the sheath at the right angle to push it back upwards and around to create the knot.The catheter did not stick in fully deflected position.The physician tried to pull back and twist on the catheter to free it but it ultimately moved the knot further proximal.After the catheter was removed there was damage to the coating of the catheter, customer suggests that the damages on the catheter shaft were a result of the knot getting undone with other catheters, sheaths, and dilators.Due to the exposed components, an electrical test was performed and catheter passed.Therefore, we can conclude all the electrical wires were perfectly insulated.Also, the outer diameters were measured and found within specifications.The catheter was introduced in an instructions for use recommended sheath and no resistance was noticed during the procedure.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 the customer complaint has been verified.

• Brand Name: THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER, INC (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer (Section G): BIOSENSE WEBSTER, INC (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer Contact: shahe garabedian ; 9098397362
• MDR Report Key: 4953467
• MDR Text Key: 24654035
• Report Number: 2029046-2015-00204
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Report Date: 07/07/2015

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: 07/31/2015
• Device Model Number: D-1327-04-S
• Device Catalogue Number: D132704
• Device Lot Number: 17057624M
• Other Device ID Number: (01)10846835009194
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2014
• 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