MAUDE Adverse Event Report: ST. JUDE MEDICAL TRANSSEPTAL NEEDLE, BRK SERIES; TROCAR

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Hypersensitivity/Allergic reaction (1907); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/13/2023

Event Type  Injury  

Event Description

During a mitraclip procedure to treat functional mitral regurgitation, the patient had an allergic reaction.Transeptal puncture was performed with abbott product.A steerable guide catheter (sgc) was then inserted into the patient.Then, additional heparin was administered due to low activated clotting time (act) levels.After this, the patient experienced desaturation, became hypotensive, tachycardic, and had right ventricle dysfunction.Manual cardio-pulmonary resuscitation (cpr) was performed, along with administering of epinephrine and fluids.Upon removal of the sterile field, it was noticed that the patient had a severe allergic reaction.It is unknown what substance caused the reaction.The patient was reported to be stable and in the intensive care unit (icu).Mr remained unchanged grade 4.The clip delivery system never entered the patient.No additional information was provided.Slowly the patient recuperated, however, blood pressure remained low and the procedure was aborted.The physician ruled out air or thromboembolism, as well as bleeding.

Manufacturer Narrative

The cause of the reported allergic reaction was the result of heparin and not related to any abbott device.

Event Description

Further information received, confirmed the allergic reaction was the result of heparin and not related to any abbott device.

• Brand Name: TRANSSEPTAL NEEDLE, BRK SERIES
• Type of Device: TROCAR
• 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
• Manufacturer (Section G): 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
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18194493
• MDR Text Key: 328826520
• Report Number: 3008452825-2023-00537
• Device Sequence Number: 1
• Product Code: DRC
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K072278
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/18/2023

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/13/2023
• Initial Date FDA Received: 11/22/2023
• Supplement Dates Manufacturer Received: 11/13/2023
• Supplement Dates FDA Received: 12/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention