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 Material Integrity Problem (2978)

Patient Problem No Information (3190)

Event Date 05/04/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The returned device was visually inspected upon receipt and it was found that the clear sensor sleeve (pebax) had reddish brown material inside.Per this condition and the event reported a scanning electron microscope (sem) analysis was carried out and it was found that pebax area was punctured and the ruptured surfaces presented evidence of damage induced by a sharp object.This condition found on the device could be related to the filtration of blood inside of the pebax.An internal corrective action has been opened to address this issue.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 customer complaint has been verified.

Event Description

It was reported that a patient underwent an atrial flutter procedure with a thermocool smarttouch bi-directional navigation catheter and after the procedure had been completed the catheter was removed and it was noted that there was blood inside the catheter near the proximal area by electrodes 3 and 4.There was no visible damage.Therefore this event was originally assessed as not reportable since the potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.The catheter was returned to biosense webster failure analysis lab for evaluation and it was discovered through scanning electron microscope (sem) analysis that the device presented a puncture in the pebax area.Therefore, this finding is indicative of a reportable event due to the break in catheter integrity.The awareness date for this record is october 14, 2015 because that is when the pebax 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: 5167525
• MDR Text Key: 29374707
• Report Number: 9673241-2015-00760
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 05/04/2015

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: 12/31/2015
• Device Model Number: D-1327-05-S
• Device Catalogue Number: D132705
• Device Lot Number: 17149714M
• Other Device ID Number: SEE H10.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/06/2015
• 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