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

Catalog Number	BNI35FJCT
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigational analysis completed on 10/3/2019.The device was visually inspected and it was found in good conditions.A second visual inspection was performed.A kink was found in the peek housing and electrode damage was observed with evidence of sharp edges.Deflection testing was performed and it was found within specifications.The catheter was deflecting correctly.A manufacturing record evaluation was performed and no internal actions were identified.The customer complaint cannot be confirmed.The root cause of the electrode damage cannot be related to the manufacturing process since there is evidence that the device was manufactured in accordance with documented specification and procedures, it could be related to the handling of the device during the procedure, however, this cannot be conclusively determined.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacture reference no: (b)(4).
Event or Problem Description
It was reported that a patient underwent an ablation procedure with a thermocool® sf nav bi-directional catheter, and the biosense webster inc.(bwi) product analysis lab (pal) found electrode damages.Initially it was reported that at the beginning of the procedure, during the mapping phase of the procedure the deflection mechanism of the catheter did not work properly.Catheter replacement resolved the issue.Surgery was not delayed and no fragments were generated.The procedure was successfully completed.No adverse patient consequences were reported.The observed deflection issue has been assessed as not mdr reportable.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.On 9/25/2019, the bwi pal received the device for evaluation.Upon initial inspection, the distal tip was observed bent.Further testing was then performed.During a second visual inspection on 10/2/2019, the bwi pal observed a kink in the peek housing, electrode damage, and sharp edges.The observed bent distal tip and kinked peek housing has been assessed as not mdr reportable.The findings of electrode damage with sharp edges has been assessed as mdr reportable malfunctions.The awareness date has been reset to 10/2/2019.

• Brand Name: THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 9180618
• Report Number: 2029046-2019-03747
• Device Sequence Number: 2811560
• Product Code: LPB
• UDI-Device Identifier: 10846835003260
• UDI-Public: 10846835003260
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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
• Report Date (Section B): 10/02/2019

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: 07/31/2020
• Device Catalogue Number: BNI35FJCT
• Device Lot Number: 17713235L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/02/2019
• Initial Report FDA Received Date: 10/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1