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

Model Number	D-1314-04-S
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/09/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.As such, the investigation will be closed.If the complaint device is received in the future we will reopen the complaint and perform the investigation as appropriate.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.(b)(4).
Event or Problem Description
It was reported that a patient underwent an ablation procedure for idiopathic ventricular tachycardia with a c3 ez steer thermocool non-nav sf catheter where the catheter partially split open at the shaft/tip junction.The damage resulted in internal wires/braiding being exposed, but did not result in any lifted or sharp rings.No difficulty was encountered while inserting or removing the catheter from the patient.The sheath in use at the time of the event is unknown.The catheter was replaced with a different one, and the case was completed without any patient consequence.Exposure to the internal components of the catheter creates a critical risk of thrombus to the patient, as does the risk of complete separation of the catheter tip.As a result, this event is mdr reportable.The awareness date for this complaint is 12/7/2016, as that is when a response was received from a bwi representative with information making this event reportable.
Additional Manufacturer Narrative
In the initial 3500a report submitted on 12/15/2016, the expiration date of the product was listed incorrectly.As a result, the udi number submitted was also incorrect.These fields have been updated with the correct values.(b)(4).
Additional Manufacturer Narrative
On 2/7/2017, 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).
Additional Manufacturer Narrative
Manufacturer's reference number: (b)(4).It was reported that a patient underwent an ablation procedure for idiopathic ventricular tachycardia with a c3 ez steer thermocool non-nav sf catheter where the catheter partially split open at the shaft/tip junction.The returned device was visually inspected, and the lumen/shaft transition was found separated.Per this condition, scanning electron microscope (sem) analysis was performed over the damaged area of the catheter, and the results showed that the external body surface was elongated at the separation.Elongation is a common characteristic of pieces which were stretched and/or pulled.Stretching and/or pulling could have been related to this observation.Per this condition, the catheter outer diameters were measured, and were found within specifications.Finally, the catheter was tested for electrical performance, and was found within specifications.A meeting was called with the manufacturing team to discuss this issue, and it was concluded that the body separation was not manufacturing related.It was also determined that there are enough process controls in place to assure the quality and integrity of the catheter bonding process and deflection mechanisms.Awareness training was performed with the relevant manufacturing process associates in order to avoid future failures of this type.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.However, based on the available analysis results, the handling of the catheter may have contributed to the failure.This failure mode does not appear to be caused by any internal bwi processes; during the manufacturing process, all catheters are inspected for visual damage prior to packaging.

• Brand Name: THERMOCOOL® SF BI-DIRECTIONAL CATHETER
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua 32599 ; MX 32599
• MDR Report Key: 6177457
• Report Number: 9673241-2016-00869
• Device Sequence Number: 10991494
• Product Code: LPB
• UDI-Device Identifier: 10846835002843
• UDI-Public: (01)10846835002843(11)160922(17)180831(10)17575330L
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P030031/S025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/10/2016

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2019
• Device Model Number: D-1314-04-S
• Device Catalogue Number: BDI35FJRT
• Device Lot Number: 17575330L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/09/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 12/15/2016
• Supplement Report FDA Received Date: 12/21/2016; 02/10/2017; 03/31/2017
• Patient Sequence Number: 1