MAUDE Adverse Event Report: BIOSENSE WEBSTER INC. EZ STEER DS BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETERS; ELECTRODE, PERCUTANEOUS, CONDUCTION TISSUE ABLATION

Model Number	BD7TCDF8L
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information received indicates that the device is not available for return, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 30219930m number, and no internal action related to the complaint was found during the review.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.(b)(4).Biosense webster manufacturer's reference number (b)(4) has two reports: mfr #: 2029046-2020-01589 for product code: bd7tcdf8l (ez steer¿ ds bi-directional electrophysiology catheter).Mfr #: 2029046-2020-01590 for product code: bd7tcdf8l(ez steer¿ ds bi-directional electrophysiology catheter).
Event or Problem Description
It was reported that a patient underwent cardiac ablation procedure with two (2) a ez steer¿ ds bi-directional electrophysiology catheters wherein procedure delay occurred.It was reported both ez steer¿ ds bi-directional electrophysiology catheter didn't work.The first ez steer¿ ds bi-directional electrophysiology catheter did not provide radiofrequency due impedance off the scale.After one hour of connection changes and contacts for assistance, another ez steer¿ ds bi-directional electrophysiology catheter was used that presented the same issue.The procedure was completed with a third catheter 4 mm.The caller stated that the consequences were procedure delay, radiofrequency exposition, severe discomfort and vein thrombosis risk.There is no report of patient consequence.Since the caller considered the delay to increase risk of thrombosis it is considered mdr reportable.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.Should more information become available in the future; the reportability decision will be reassessed.

• Brand Name: EZ STEER DS BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETERS
• Common Device Name: ELECTRODE, PERCUTANEOUS, CONDUCTION TISSUE ABLATION
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• MDR Report Key: 10757154
• Report Number: 2029046-2020-01589
• Device Sequence Number: 19632174
• Product Code: LPB
• UDI-Device Identifier: 10846835002539
• UDI-Public: 10846835002539
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P950005/S19
• 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): 09/30/2020

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: 05/03/2022
• Device Model Number: BD7TCDF8L
• Device Catalogue Number: BD7TCDF8L
• Device Lot Number: 30219930M
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 10/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR