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

Model Number D-1327-05-S

Device Problem Break (1069)

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

Event Date 12/07/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Due to the august 2015 fda maintenance where the 3500a codes were updated, the 3500a codes will be added until the biosense webster system is also updated.Therefore the following codes apply: (b)(4).Upon receipt, the catheter was visually inspected and the shaft was observed bent and broken with internal wires exposed and reddish brown material.Per the exposed wires, an electrical test was performed and current leakage was observed on the electrodes.Further examination revealed that the broken shaft was the root cause of the electrical malfunction.Additional information received indicates that the catheter was forced to be inserted into a (8fr) sheath which is smaller than the recommended by the ifu (8.5 fr).This might contributed to the catheter damage.An internal corrective action was created to address the thermocool smart touch broken shaft issue.A deflection test was performed and the 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.Based on available analysis finding results, the failure mode does not appear to be caused by any internal bwi processes.The root cause appears to be related to the fact that the catheter was introduced into a sheath with a smaller diameter that recommended by the instructions for use.

Event Description

It was reported that a patient underwent an idiopathic ventricular tachycardia procedure with a thermocool® smarttouch® bi-directional navigation catheter and a deflection issue occurred.The right side of the heart was mapped and then the physician decided to change the sheath due to the sheath being uncomfortable.The customer used a rangio 8f short femoral sheath which was incompatible for the catheter.When the physician changed the sheath, he forced the catheter into the new sheath, but he couldn't fit it in.Then, he said the catheter couldn't deflect.The catheter was possibly damaged.The catheter was replaced.There was no exposed wire on the catheter.The catheter was changed and the procedure was completed with no patient consequence.This event was assessed as not mdr reportable because the potential risk that it could cause or contribute to a serious injury or death was remote.The biosense webster failure analysis lab received the device on (b)(6) 2016 for device evaluation and it was discovered that the shaft was bent and broken open with reddish brown material.In addition, broken, sharp braid wires with internal parts also exposed about 28 cm from the handle was also discovered.Additional information was received on the returned catheter condition.The exposed braid and internal parts was not seen prior to sending the catheter back.These findings have been assessed as mdr reportable because this could potentially cause patient harm.The awareness date for this record is (b)(6) 2016 because that is when the reportable damage was discovered.

• 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 32599 ; MX 32599
• Manufacturer Contact: joaquin kurz ; 9497893837
• MDR Report Key: 5455721
• MDR Text Key: 39261814
• Report Number: 9673241-2016-00122
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: TU
• 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: Initial
• Report Date: 12/28/2015

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: 02/29/2016
• Device Model Number: D-1327-05-S
• Device Catalogue Number: D132705
• Device Lot Number: 17194408M
• Other Device ID Number: SEE H10.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/28/2015
• Initial Date FDA Received: 02/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2015
• 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