MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number D134804

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/23/2018

Event Type  malfunction  

Manufacturer Narrative

No device was received for analysis at the time of submission of the initial 3500a.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.Device history record (dhr) review cannot be conducted because no lot number was provided by the customer.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.(b)(4).

Event Description

It was reported that at the end of the procedure, the physician noticed a fine film at the tip of the catheter which was not present at the beginning of the procedure.No patient consequences were reported.Multiple attempts have been made to gain clarification on the type of material observed on the tip of the catheter; however, no response has been made available.Therefore, this complaint will be conservatively reported as foreign material.

Manufacturer Narrative

On 4/26/2018, additional information was received which confirmed that the foreign material observed on the tip of the catheter was not noticed prior to use of the catheter on patient.The foreign material appeared during the procedure when the physician removed the catheter to finish the procedure.It was also clarified that the material was like a clear film on the catheter tip.There was no issue with the flow, but the water passed through the foreign material.The physician was concern about the material observed.Additionally, a picture was provided; however, it¿s not clear enough to determine what type of material it is.Manufacturer's ref # (b)(4).

Manufacturer Narrative

On 1/16/2019, the complaint product was received by biosense webster inc.¿s (bwi) product analysis lab (pal) for evaluation.Initial visual analysis found the returned catheter ¿in good normal conditions.¿ based on the received product, the lot # was verified as 30001926l, as such lot # has been populated.On 1/24/2019, the catheter was evaluated with fourier transform infrared spectroscopy (ft-ir).The ft-ir results indicate the foreign material was primarily composed of a biological-based material, presumably human tissue.As such, the customer¿s reported event of ¿a fine film at the tip of the catheter¿ is no longer reportable since the foreign material was presumably human tissue.Further analysis of the catheter showed that the integrity of the device is maintained and there is no evidence of exposed internal components, other foreign material, clot formation or sharp edges.Therefore, there is no risk to the patient.Since this event has already been reported to fda, biosense webster inc.Will continue to submit supplemental mdrs to fda with any updates even though this event is no longer considered mdr reportable.Device evaluation details: the device evaluation has been completed.The device was inspected and foreign material was observed on the dome.A fourier transform infrared spectroscopy test (ftir) was performed and the results showed that the foreign material was primarily composed of a biological-based material, presumably human tissue.A manufacturing record evaluation was performed for the finished device and no non-conformances related to the reported complaint condition were identified.The customer complaint was confirmed.The root cause of the foreign material cannot be determined since there is evidence that the device was manufactured in accordance with documented specification and procedures, it could be related to the procedure.Manufacturer¿s ref # (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 7354138
• MDR Text Key: 103278445
• Report Number: 2029046-2018-01329
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010176
• UDI-Public: 10846835010176
• Combination Product (y/n): N
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 02/23/2018

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: 12/13/2018
• Device Catalogue Number: D134804
• Device Lot Number: 30001926L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2019
• Initial Date Manufacturer Received: 02/23/2018
• Initial Date FDA Received: 03/20/2018
• Supplement Dates Manufacturer Received: 04/26/2018; 01/16/2019
• Supplement Dates FDA Received: 05/03/2018; 02/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1