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 Material Separation (1562); Device Dislodged or Dislocated (2923); Material Integrity Problem (2978); Temperature Problem (3022)

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

Event Date 09/14/2015

Event Type  malfunction  

Manufacturer Narrative

Due to the (b)(4) 2015 fda maintenance where the 3500a codes were updated, the 3500a (b)(4).Contact office and manufacturing site should reflect: (b)(4).It was reported that there was an error ¿temperature limiter¿ shown on the stockert when smarttouch thermocool ablation catheter was used during an afib.Ablation procedure.The returned device was visually inspected upon receipt and white crystals were found at the pebax area.Per this condition a scanning electron microscope (sem) testing was performed over the damaged area of catheter and it was found that there was evidence of displacement material between pu and pebax induced by an unknown object.This condition might contribute to the white crystals found.Per the event reported, the catheter was tested for electrical performance, temperature response and stockert compatibility and it was found within specifications.An irrigation test was performed and the catheter passed, no occlusion was observed.The device history record (dhr) was reviewed and verified that the device was manufactured in accordance with documented specification and procedures.The customer complaint regarding a high temperature cannot be confirmed.A corrective action was created to address the damaged pebax on smart touch.

Event Description

This complaint is originally assessed as a mdr non-reportable high temperature event.It was reported that there was an error "temperature limiter" shown on the stockert when smarttouch thermocool ablation catheter was used during an afib.Ablation procedure.The procedure was completed by replacing catheter.No patient consequence was reported.This complaint is re-assessed to mdr reportable per bwi failure analysis lab findings on (b)(6) 2015.Scanning electron microscope (sem) results show that the separation section presented evidence of displacement material between the pu and pebax.This is reportable because it compromised the integrity of the catheter and pose potential risk to patients.The awareness date of this complaint is reset to 11/18/2015 based on lab findings on 11/18/2015.

• 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: joaquin kurz ; 9497893837
• MDR Report Key: 5287078
• MDR Text Key: 33862847
• Report Number: 9673241-2015-00898
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/14/2015

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-1348-05-S
• Device Catalogue Number: D134805
• Device Lot Number: 17156722L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/14/2015
• Initial Date FDA Received: 12/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/28/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1