MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) THERMOCOOL® SMARTTOUCH® SF BI-DIRECTIONAL NAV CATHETER; SIMILAR DEVICE D132701, PMA # P030031/S053

Model Number D-1348-05-S

Device Problems Peeled/Delaminated (1454); Device Contamination with Body Fluid (2317); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/29/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during a procedure, the customer experienced force issue with a smart touch bidirectional sf catheter.The issue was resolved by changing the catheter without any patient consequence.This issue is not reportable.In addition, when the catheter was removed from the patient, the customer noticed blood inside the tip of catheter.This issue was not reportable since there was no exposure of internal components or any evidence that the integrity of the catheter has been compromised was reported.Upon receiving the product in biosense webster lab on july 17th 2015, it was noticed that clear sensor sleeve has damage pu margin on proximal side of ring #1 allowing reddish brown material to enter inside the sleeve.Pu is peeling on the proximal side of ring #1, making this event reportable.Investigation is still in progress.A supplemental report on device evaluation will be submitted.

Manufacturer Narrative

(b)(4).It was reported that during a procedure, the customer experienced force issue with a smart touch bidirectional sf catheter.The issue was resolved by changing the catheter without any patient consequence.This issue is not reportable.In addition, when the catheter was removed from the patient, the customer noticed blood inside the tip of catheter.This issue was not reportable since there was no exposure of internal components or any evidence that the integrity of the catheter has been compromised was reported.Upon receiving the product in biosense webster lab on july 17th 2015, it was noticed that clear sensor sleeve has damage pu margin on proximal side of ring #1 allowing reddish brown material to enter inside the sleeve.Pu is peeling on the proximal side of ring #1, making this event reportable.Upon received the catheter was visually inspected and it was found that clear sensor sleeve has damage pu margin on proximal side of ring #1 allowing reddish brown material to enter inside the sleeve.Pu is peeling on the proximal side of ring #1 scanning electron microscope (sem) results showed that the damage observed on pu presented evidence of damages by a sharp point object, it could be observed that there is a kind of fissure, the damage observed could probably cause the blood filtration inside of pebax then the catheter was tested per the reported event on eeprom and calibration test and the catheter passed eeprom test but failed carto test.Error 106 appears.The catheter was then dissected and it was determined that the root cause was an internal failure of the sensor.The device history record (dhr) was reviewed.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.Customer complaint has been confirmed.

• Brand Name: THERMOCOOL® SMARTTOUCH® SF BI-DIRECTIONAL NAV CATHETER
• Type of Device: SIMILAR DEVICE D132701, PMA # P030031/S053
• 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: shahe garabedian ; 9098397362
• MDR Report Key: 4963212
• MDR Text Key: 24708975
• Report Number: 9673241-2015-00501
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Report Date: 06/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2015
• Device Model Number: D-1348-05-S
• Device Catalogue Number: D134805
• Device Lot Number: 17107295L
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2014
• 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