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

Model Number D-1336-02-S

Device Problem Break (1069)

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

Event Date 09/21/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Further information and pictures received indicates that there was no braid exposed.However, during the analysis a visual inspection under a higher microscope magnification was performed and it was noticed that shaft was broken and braid was exposed.The rupture point and stress marks look like it might have happened while bending and unbending the product.An internal corrective action was created to address the thermocool smart touch broken shaft issue.During manufacturing all the catheters are inspected for visual damages before packaging.On-line inspections are in place to prevent this type of damage/defect from leaving the facility.Due to the exposed parts, an electrical test was performed and catheter passed.Therefore, we can conclude all the electrical wires were perfectly insulated.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 a persistent atrial fibrillation procedure with a thermocool® smarttouch® uni-directional navigation catheter and a bent shaft occurred.After pulling the catheter out of the st.Jude medical sl1, 8.5f sheath, the physician recognized a structural alteration of the catheter shaft 12.5 cm behind the distal electrode.The shaft appeared to be broken.The procedure was completed with no patient consequence.Upon request additional information was received on the event.There were no exposed wires, no resistance or difficulty during insertion or removal of the catheter and the catheter was not pre-shaped.This event was originally assessed as not mdr reportable since the potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.The biosense webster failure analysis lab received the device for analysis.It was discovered that the shaft was broken approximately 12.5cm from the tip dome and exposed braid could be seen.This event was reassessed as mdr reportable due to the wires being exposed.The catheter integrity is not maintained and internal components are exposed to the patient which poses a potential risk.The awareness date for this record is (b)(6) 2016 because that is when the exposed wire was discovered.

• Brand Name: THERMOCOOL® SMARTTOUCH® UNI-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: 5370173
• MDR Text Key: 36491591
• Report Number: 9673241-2016-00032
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 09/22/2015

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: 04/30/2016
• Device Model Number: D-1336-02-S
• Device Catalogue Number: D133602
• Device Lot Number: 17236490M
• Other Device ID Number: SEE H10.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/21/2015
• Initial Date FDA Received: 01/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/25/2015
• 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