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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL INQUIRY¿ STEERABLE DIAGNOSTIC CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
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ST. JUDE MEDICAL INQUIRY¿ STEERABLE DIAGNOSTIC CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING Back to Search Results
Model Number IBI-81174
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Cardiac Perforation (2513)
Date of Event 05/21/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported pericardial effusion could not be conclusively determined.Per the ifu, cardiac perforation is a known risk during the use of this device.
 
Event or Problem Description
Related manufacturing ref: 3008452825-2019-00275, 3008452825-2019-00274, 3008452825-2019-00273.Following an atrial fibrillation procedure, a pericardial effusion was noted.In the recovery room, the patient became hypotensive and a pericardial effusion was diagnosed.A pericardiocentesis was performed to stabilize the patient.There were no performance issues with any abbott device.
 
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Brand Name
INQUIRY¿ STEERABLE DIAGNOSTIC CATHETER
Common Device Name
CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
Manufacturer (Section D)
ST. JUDE MEDICAL
parque industrial, zona franca coyol s.a.
edificio #44b, calle 0, avenida 2, coyol
alajuela, costa rica 1897- 4050
CS  1897-4050
MDR Report Key8686983
Report Number3008452825-2019-00276
Device Sequence Number437893
Product Code DRF
UDI-Device Identifier05414734303361
UDI-Public05414734303361
Combination Product (Y/N)N
Initial Reporter CountryFR
PMA/510(K) Number
K961924
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 06/11/2019
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 Expiration Date12/31/2021
Device Model NumberIBI-81174
Device Catalogue NumberIBI-81174
Device Lot Number6830367
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/21/2019
Initial Report FDA Received Date06/11/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
AGILIS¿ STEERABLE INTRODUCER; TACTICATH¿ CONTACT FORCE ABLATION CATHETER; TACTICATH¿ CONTACT FORCE ABLATION CATHETER
Outcome Attributed to Adverse Event Required Intervention;
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