MAUDE Adverse Event Report: COVIDIEN LP - SUPERDIMENSION INC EMPRINT; ELECTROSURGICAL, CUTTING & COAGULATION & ACCES

Model Number	CAGEN1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, the ablation catheter with thermosphere technology were recalled since the device were mislabeled with the incorrect expiration date.
Additional Manufacturer Narrative
Concomitant products: ca108l1, ablation catheter kit ca108l1 emprint (lot#520200); sdatsw01, sdatsw01 access tool straight wire (lot#519245); sdk4000-ft, sdk4000-ft kit edge 180-ft x1 (lot#520562); not-mdt-prod, non-medtronic product (sn:unknown); aas00161-36, aas00161-36 superd navigation systemx1 (b)(4).If information is provided in the future, a supplemental report will be issued.

• Brand Name: EMPRINT
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCES
• Manufacturer (Section D): COVIDIEN LP - SUPERDIMENSION INC; 161 cheshire lane, suite 100; plymouth MN 55441
• Manufacturer (Section G): COVIDIEN LP - SUPERDIMENSION INC; 161 cheshire lane, suite 100; plymouth MN 55441
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 16402171
• Report Number: 3004962788-2023-00023
• Device Sequence Number: 5379149
• Product Code: GEI
• UDI-Device Identifier: 10884521190771
• UDI-Public: 10884521190771
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K133821
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/19/2023

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 Model Number: CAGEN1
• Device Catalogue Number: CAGEN1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2023
• Initial Report FDA Received Date: 02/20/2023
• Date Device Manufactured: 08/07/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown