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

Model Number D-1336-01-S

Device Problems Bent (1059); Break (1069); Deflation Problem (1149)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/23/2015

Event Type  malfunction  

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.(b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation procedure with a thermocool smarttouch uni-directional navigation catheter and a deflection issue occurred.Halfway through the case, the puller wire of the catheter broke causing the catheter to stop fully deflecting towards one of the curves.The catheter was replaced and the issue was resolved.The procedure was completed without patient consequence.This event was originally assessed as not mdr reportable since the potential risk that it could cause or contribute to a serious injury or death is remote.The biosense webster failure analysis lab received the device for evaluation on november 8, 2015 and during visual inspection it was discovered that the shaft was bent and wrinkled with broken braided wires sharp and exposed about 9 cm from the proximal end of the piston of the handle.Upon request additional information was received on the finding.The catheter was withdrawn through the st.Jude fast cath 8.5f sheath without difficulty.This condition was not noticed prior to use of the catheter, upon withdrawal or prior to sending the catheter back.The bend is not mdr reportable; however, the finding of broken braided wires sharp and exposed is reportable because it poses a risk to the patient.The awareness date for this record is november 8, 2015 because that is when the damage was discovered.

Manufacturer Narrative

(b)(4).It was reported that a patient underwent an atrial fibrillation procedure with a thermocool® smarttouch® uni-directional navigation catheter and a deflection issue occurred.Upon receipt, the catheter was visually inspected and shaft was found bent, wrinkled with broken braid exposed, which is why this complaint was reported to the fda.Further information received stated that physical damage of the catheter was not noticed by the costumer.It appears the damage was due to external force while bending and unbending.An internal corrective action was opened to address broken shaft issues.Per the complaint reported, the catheter was tested for deflection and the catheter failed.An x-ray of the catheter was taken and it was noticed that the t-bar slid down from its place.An internal corrective action was created to address the t-bar 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.

• 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: 5255497
• MDR Text Key: 32479239
• Report Number: 9673241-2015-00875
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2016
• Device Model Number: D-1336-01-S
• Device Catalogue Number: D133601
• Device Lot Number: 17276016M
• Other Device ID Number: SEE H10.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2015
• 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