MAUDE Adverse Event Report: BIOSENSE WEBSTER INC NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Catalog Number	NI75TCBH
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: the returned device was visually inspected and it was found in normal conditions.However, the packaging was not returned.For this reason, the analysis was unable to be performed.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 since the packaging was not returned and it was unable to analyzed.However, there is evidence that the device was manufactured in accordance with documented specification and procedures.(b)(4).
Event or Problem Description
It was reported that a patient underwent a procedure with a navi-star¿ thermo-cool¿ electrophysiology catheter.During the procedure, the physician found the inner package was damaged.He exchanged the catheter to complete the procedure.Additional clarification was received on the event on january 1, 2018 which confirmed that the product was never used on the patient.The pictures attached reflects that the device packaging (pouch) was worn and ragged; however, there was no indication that the sterility of the device could be compromised due to this issue.This initial inner package (pouch) issue was assessed as not reportable.If the packaging of the device was worn, bent, ragged, contained a cut or slit, or appear ripped; however, there was no damage to the pouch nor other sterility compromises, then the potential risk that it could cause or contribute to a death or serious injury was remote.Additional information was received on may 14, 2018 which clarified that the damage observed on the inner package represented a risk to the sterility of the device.Therefore, since there was a risk to the sterility of the device, this issue has now been reassessed as a reportable malfunction.The awareness date will be reset to may 14, 2018, the date on which the reportable information became available.

• Brand Name: NAVI-STAR¿ THERMO-COOL¿ 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: 7595014
• Report Number: 2029046-2018-01661
• Device Sequence Number: 130806
• Product Code: OAD
• UDI-Device Identifier: 10846835008333
• UDI-Public: 10846835008333
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P030031
• 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): 05/14/2018

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: 03/31/2019
• Device Catalogue Number: NI75TCBH
• Device Lot Number: 17452071M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2018
• Initial Date Received by Manufacturer: 05/14/2018
• Initial Report FDA Received Date: 06/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1