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

Model Number D-1327-01-S

Device Problems Bent (1059); Difficult to Insert (1316); Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/14/2015

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation procedure with a smart touch bidirectional catheter and resistance with the sheath occurred along with a bend in the shaft of the catheter.The shaft of the smart touch catheter was kinked and could not be inserted into the agilis 8.5f sheath with the insertion tool.The issue was resolved by changing the catheter to another one.The procedure was completed without patient consequence.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.This event was originally assessed as not reportable as there was no indication that there were any exposed components.Therefore, both of the issues potential to cause or contribute to a death or serious injury, or other significant adverse event, is remote.The catheter was received for analysis and it was discovered that shaft was broken about 8mm from the tip lumen transition showing internal parts.The user did notice a kink however it is unsure if the user noticed the damage with internal parts exposed.The analysis finding is indicative of a reportable event because the catheter integrity was not maintained and internal components are exposed to patient.The awareness date for this record is (b)(6) 2015 because that is the day the damage was found.

Manufacturer Narrative

(b)(4).Upon receipt, the device was visually inspected and the shaft was found broken about 8mm from the tip lumen transition showing internal parts.It is unknown how this condition was generated however it appears the damage could be related to external force on catheter shaft.An internal corrective action has been opened to address this issue.Due to this shaft condition, an electrical test was performed and catheter passed.Therefore, we can conclude all the electrical wires were perfectly insulated.Then per the reported event, a dimensional test was performed and catheter passed.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 instructions for use states that careful catheter manipulation must be performed and avoid twisting the catheter to prevent any damage.The reported 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. (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 3259 9; MX 32599
• Manufacturer Contact: shahe garabedian ; 9098397362
• MDR Report Key: 4847673
• MDR Text Key: 5931294
• Report Number: 9673241-2015-00370
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2015
• Device Model Number: D-1327-01-S
• Device Catalogue Number: D132701
• Device Lot Number: 17130121M
• Other Device ID Number: (01)10846835009163
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/03/2014
• 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