MAUDE Adverse Event Report: MPRI MARINR; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number	075302
Medical Device Problem Code	Device Expiration Issue (1216)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that during a radiofrequency procedure, the catheter was after its expiration.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: the ep catheter was returned and analyzed.Mechanical tests were performed, and visual analysis was performed.The expiry date of the catheter was 06.Nov.2017, and the date of the event was (b)(6) 2018.Therefore, the time of the use was already passed the expiry date.The issue was confirmed through product analysis.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: MARINR
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 7417944
• Report Number: 2649622-2018-04970
• Device Sequence Number: 10784143
• Product Code: LPB
• UDI-Device Identifier: 00613994947246
• UDI-Public: 00613994947246
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P930029
• 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,Followup
• Report Date (Section B): 10/03/2018

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: 11/06/2017
• Device Model Number: 075302
• Device Catalogue Number: 075302
• Device Lot Number: FA53292
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2018
• Initial Date Received by Manufacturer: 02/09/2018
• Supplement Date Received by Manufacturer: 07/09/2018; 08/08/2018
• Initial Report FDA Received Date: 04/10/2018
• Supplement Report FDA Received Date: 07/17/2018; 10/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1