MAUDE Adverse Event Report: BIOSENSE WEBSTER INC EZ STEER¿ NAV DS BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Catalog Number	BN7TCDF8L
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/12/2019
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.We are working on the manufacture record evaluation (mre), once we get more information it will be submitted in the supplemental.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 for right atrial flutter with a ez steer¿ nav ds bi-directional electrophysiology catheter, and a broken tip issue occurred.There was some resistance when inserting the catheter.When the catheter was pulled, the tip was bent with exposed wires.However, there were no sharp or lifted rings.Catheter replacement resolved the issue.No adverse patient consequences were reported.The observed broken tip has been assessed as an mdr reportable malfunction.
Additional Manufacturer Narrative
It was reported that a patient underwent an ablation procedure for right atrial flutter with a ez steer¿ nav ds bi-directional electrophysiology catheter, and a broken tip issue occurred.The biosense webster inc.Product analysis lab received the device for evaluation.The investigational analysis completed on 1/10/2020.The device was visually inspected, and it was found in good conditions.Then, the catheter outer diameter was measured, and it was found to be within specifications.A manufacturing record evaluation was performed for the finished device, and no internal actions were found during the review.The customer complaint cannot be confirmed.The catheter passed specifications.Manufacture reference no: (b)(4).

• Brand Name: EZ STEER¿ NAV DS BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 9419549
• Report Number: 2029046-2019-03963
• Device Sequence Number: 11385433
• Product Code: OAD
• UDI-Device Identifier: 10846835003000
• UDI-Public: 10846835003000
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P010068/S6
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2019

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: 07/11/2022
• Device Catalogue Number: BN7TCDF8L
• Device Lot Number: 30256443M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2019
• Initial Date Received by Manufacturer: 11/12/2019
• Supplement Date Received by Manufacturer: 12/23/2019
• Initial Report FDA Received Date: 12/05/2019
• Supplement Report FDA Received Date: 01/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1