MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. COOL POINT¿ IRRIGATION PUMP; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number	IBI-89003
Medical Device Problem Code	Intermittent Energy Output (4025)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation results will be provided in a subsequent submission.
Event or Problem Description
During an ep procedure as ablation started and the tubing set was purged, the pump indicated a short circuit as it was turning on and off.When the pump was on it displayed a display alarm.Different positions were tried with no success.The procedure was cancelled.
Additional Manufacturer Narrative
One cool point¿ irrigation pump was received for evaluation.Visual inspection revealed the pump door was fractured and could not be fully opened.Additionally, a tubing set could not be installed in the pump.Therefore, testing was discontinued.The device met specifications prior to release from abbott manufacturing facilities as supported by the receiving inspection record.The cause of the fractured pump door is consistent with damage during handling.The cause of the reported short circuit /communication issue and subsequent cancellation remain unknown.The cause of the fractured pump door is consistent with damage during handling.

• Brand Name: COOL POINT¿ IRRIGATION PUMP
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 2375 morse ave; irvine CA 92614
• MDR Report Key: 8823745
• Report Number: 2030404-2019-00063
• Device Sequence Number: 2839251
• Product Code: OAD
• UDI-Device Identifier: 05415067008985
• UDI-Public: 05415067008985
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: P060019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: IBI-89003
• Device Catalogue Number: IBI-89003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/10/2019
• Supplement Date Received by Manufacturer: 08/23/2019
• Initial Report FDA Received Date: 07/24/2019
• Supplement Report FDA Received Date: 08/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 43 YR
• Patient Weight: 105