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 Problems Break (1069); Device Operates Differently Than Expected (2913); Device Contamination with Chemical or Other Material (2944); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/02/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The bwi failure analysis lab received the device for evaluation.Upon receipt of the catheter, it was visually inspected and it was found that the pebax had a deep cut about 1.2mm from the proximal end of electrode ring #1.Inside the pebax, there was reddish brown material and some type of off white crystals, likely dried saline.Due to this condition, a spectrum electro magnetic (sem) analysis was performed and results show that the external surface exhibited evidence of scratches near the pinhole.It is possible that an unknown object hit and punctured the pebax.An internal corrective action has been opened to investigate the pebax damage on smart touch catheter.Additionally, eds analysis was performed for the white crystals on the pebax.Results showed that the particle was composed of elemental carbon, oxygen, sodium, sulfur, chlorine, potassium, calcium and iodine.The presence of sodium and chlorine on the analyzed foreign matter suggests that a saline solution could be present on the device.The catheter outer diameters were measured and were found within specifications.Also, it was introduced in the ifu recommended sheath.No resistance was observed while using it.The device history record (dhr) was reviewed and no anomalies were found.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.Customer complaint has been confirmed.An internal corrective action has been opened to investigate the pebax damage on smart touch catheter.

Event Description

It was reported that a patient underwent a procedure with a smart touch bidirectional catheter and it was found during the biosense webster analysis that there was pebax damage.It was originally reported that blood entered into a spring part between electrode 2 and 3 when the catheter was removed from the cardiac cavity after placing the sheath.The issue was resolved by changing the catheter.The procedure was completed without patient consequence.Follow up investigation was performed to clarify the event and it was stated that there was no information stating that there was physical damage.Foreign material was found underneath the pebax.However, there was no damage to the pebax integrity reported.Therefore, the potential that it could cause or contribute to a death or serious injury, or other significant adverse event, was remote.This event was assessed as not reportable.During the biosense webster failure analysis lab analysis on august 23, 2015, it was found that there was pebax damage with foreign material inside.Since this damage represents a loss of integrity, this issue has been assessed as a reportable malfunction.The awareness date is reset to august 23, 2015.

• 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: 5094260
• MDR Text Key: 26782629
• Report Number: 9673241-2015-00652
• 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: company representative,foreig
• Reporter Occupation: Other
• Report Date: 07/02/2015

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: 03/31/2016
• Device Model Number: D-1327-05-S
• Device Catalogue Number: D132705
• Device Lot Number: 17218050M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/16/2015
• 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