MAUDE Adverse Event Report: ST. JUDE MEDICAL, COSTA RICA LTDA INQUIRY ¿ STEERABLE DIAGNOSTIC CATHETER; CATHETER, ELECTRODE RECORDING

Model Number	IBI-81531
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	08/28/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Related manufacturer reference number: 9680001-2018-00138, 3005334138-2018-00323.During a pulmonary vein isolation ablation procedure a pericardial effusion occurred.During mapping of the left atrium the patient became hypotensive.An echocardiogram revealed a pericardial effusion, for which a pericardiocentesis was performed to stabilize the patient.There were no performance issues with any abbott device.
Additional Manufacturer Narrative
One decapolar, inquiry steerable diagnostic catheter was received for evaluation.The catheter met specifications for electrical testing.The catheter deflected when actuating the steering mechanism; however, the catheter did not deflect in the correct shape according to specifications, due to bend in the shaft.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the bend is consistent with damage during use.The cause of the reported pericardial effusion cannot be conclusively determined.Per the ifu, vascular perforation is an inherent risk of any electrode placement.

• Brand Name: INQUIRY ¿ STEERABLE DIAGNOSTIC CATHETER
• Common Device Name: CATHETER, ELECTRODE RECORDING
• Manufacturer (Section D): ST. JUDE MEDICAL, COSTA RICA LTDA; 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: 7877401
• Report Number: 3008452825-2018-00312
• Device Sequence Number: 192373
• Product Code: OAD
• UDI-Device Identifier: 05414734304788
• UDI-Public: 05414734304788
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K961924
• 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): 10/22/2018

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 Expiration Date: 04/30/2021
• Device Model Number: IBI-81531
• Device Lot Number: 6478605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/28/2018
• Supplement Date Received by Manufacturer: 10/17/2018
• Initial Report FDA Received Date: 09/14/2018
• Supplement Report FDA Received Date: 10/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ADVISOR HD CATHETER; TACTICATH CATHETER; ADVISOR HD CATHETER; TACTICATH CATHETER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Weight: 82