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	BN7TCFJ8L
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/24/2018
Type of Reportable Event	Malfunction
Additional 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.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) for the lot number 30096829m has been reviewed and it was verified that the device was manufactured in accordance with documented specifications and procedures.Manufacturer¿s ref # (b)(4).
Event or Problem Description
A male patient underwent a procedure with a ez steer¿ nav ds bi-directional electrophysiology catheter wherein pre-op, the packaging of the catheter was compromised.At the beginning of the procedure when the physician asked to get the catheter, when the packaging was opened, the distal end of the packaging and the catheter handle fell on the ground.Sterility of the product was compromised.The plastic packaging was not ¿clipped¿ correctly causing the catheter to fall.The catheter was exchanged, and they continued with the procedure.Product never used on patient.No patient consequences were reported.
Additional Manufacturer Narrative
The bwi failure analysis lab received the device for evaluation on 11/26/2018.Initial visual analysis indicate, "the returned product looks normal.The box nor any of its plastic parts was returned with the product." 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.Manufacturer's ref # (b)(4).
Additional Manufacturer Narrative
A male patient underwent a procedure with a ez steer¿ nav ds bi-directional electrophysiology catheter wherein pre-op, the packaging of the catheter was compromised.At the beginning of the procedure when the physician asked to get the catheter, when the packaging was opened, the distal end of the packaging and the catheter handle fell on the ground.Sterility of the product was compromised.Product investigation details: the product investigation has been completed.The device was visually inspected and it was found in good conditions.No analysis was performed since the packaging was not returned.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.During manufacturing process, all the catheters are inspected for visual damages before packaging.On line inspections and functional tests are in place to prevent this type of failure from leaving the facility.The customer complaint cannot be confirmed.Manufacturer¿s ref # (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: 8080281
• Report Number: 2029046-2018-02297
• Device Sequence Number: 204019
• Product Code: OAD
• UDI-Device Identifier: 10846835003048
• UDI-Public: 10846835003048
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P010068/S6
• 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
• Report Date (Section B): 10/24/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/01/2021
• Device Catalogue Number: BN7TCFJ8L
• Device Lot Number: 30096829M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2018
• Initial Date Received by Manufacturer: 10/24/2018
• Supplement Date Received by Manufacturer: 11/26/2018; 12/12/2018
• Initial Report FDA Received Date: 11/16/2018
• Supplement Report FDA Received Date: 12/03/2018; 01/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1