MAUDE Adverse Event Report: ST. JUDE MEDICAL, COSTA RICA LTDA (AFD) FLEXABILITYABLATION CATHETER, UNI-D, CURVE D; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number	A701157
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One quadripolar, uni-directional, curve d, flexability ablation catheter was received for evaluation.Upon visual inspection, the distal tip of the catheter was found to be fractured.No other visual anomalies were noted.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information provided and the investigation performed, the cause of the fractured tip was unable to be determined.
Event or Problem Description
This report is to advise of an event observed during analysis confirming a fractured tip.

• Brand Name: FLEXABILITYABLATION CATHETER, UNI-D, CURVE D
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): ST. JUDE MEDICAL, COSTA RICA LTDA (AFD); parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• MDR Report Key: 11380282
• Report Number: 3008452825-2021-00114
• Device Sequence Number: 11724326
• Product Code: OAD
• UDI-Device Identifier: 05415067011497
• UDI-Public: 05415067011497
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P110016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/25/2021

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: 02/28/2023
• Device Model Number: A701157
• Device Catalogue Number: A701157
• Device Lot Number: 7432322
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2021
• Initial Report FDA Received Date: 02/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1