MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER; SIMILAR DEVICE D133601, PMA # P030031/S053

Model Number D-1336-04IL-S

Device Problems Peeled/Delaminated (1454); Device Contamination with Chemical or Other Material (2944); Torn Material (3024)

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

Event Date 08/02/2015

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 a procedure with a smart touch unidirectional catheter and the bwi failure analysis lab noted the returned catheter conditions of the shaft torn, black fibers were found adhered to the catheter and polyurethane was described to be peeling on the catheter.It was initially reported that during the procedure, the catheter was broken.They changed the catheter.The procedure was completed with no patient consequence.It was clarified that there was no electrode ring damage, no wires exposed or physical damage observed on the catheter.The catheter was not used in the patient.A picture was provided.However, the picture was not clear.With the information available reflecting that there was no loss of integrity of the catheter, this issue was assessed as not reportable.The biosense webster failure analysis lab received the catheter and it was noted on august 20, 2015 that the catheter shaft was bent, wrinkled and torn about 10.8cm from the distal end of the tip dome.The catheter shaft had polyurethane (pu) smears from the transition with the tip lumen to the sleeve area of the handle.The catheter shaft had pu smears and it was peeling about 19.5 cm from the handle.The pu smears had gray and black foreign fibers about 22.5cm from handle.The black foreign fibers started to peel away from the pu smear.The catheter shaft had pu smears starting to peel about 24.8 cm from the handle.Since the catheter was torn, the integrity was not maintained and this issue was within the usable length, this issue was assessed as a reportable malfunction.Additionally, black fibers were found adhered to the catheter and there was pu that was described to be peeling on the catheter.These additional descriptions are being conservatively assessed as reportable.The awareness date for this record is august 20, 2015.

Manufacturer Narrative

(b)(4).It was reported that a patient underwent a procedure with a smart touch unidirectional catheter.It was reported that during the procedure, the catheter was broken.They changed the catheter.The procedure was completed with no patient consequence.Upon receipt, the catheter was visually inspected and the shaft was found bent, wrinkled and torn about 10.8cm from the distal end of the tip dome.Rupture point and stress marks look like it might have occurred while bending and unbending the product.Further information received indicates that the catheter was not inside the patient when the failure occurred.An internal corrective action has been opened to investigate the thermocool smart touch broken shaft issue.Continuing with the visual inspection, a foreign material apparently polyurethane (pu) was found smeared with grey and black foreign fibers.However, during a second visual inspection, these findings were not located.They might have gotten lost during decontamination or the shipping process.During the manufacturing process, several on line inspections are in place to prevent this type of damage/defect from leaving the facility.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 regarding a breakage on the catheter has been verified.An internal corrective action has been opened to investigate this issue.

• Brand Name: THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: SIMILAR DEVICE D133601, 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: 5086391
• MDR Text Key: 26495688
• Report Number: 9673241-2015-00643
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 08/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2016
• Device Model Number: D-1336-04IL-S
• Device Catalogue Number: D133604IL
• Device Lot Number: 17214199M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/10/2015
• 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