MAUDE Adverse Event Report: ABBOTT VASCULAR G4 STEERABLE GUIDING CATHETER; CATHETER, STEERABLE

Model Number N/A

Device Problem Leak/Splash (1354)

Patient Problems Air Embolism (1697); Non specific EKG/ECG Changes (1817); Low Blood Pressure/ Hypotension (1914); Myocardial Infarction (1969); Cardiogenic Shock (2262)

Event Date 02/14/2022

Event Type  Injury  

Manufacturer Narrative

The customer reported the device is not returning.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

This is filed to report the loss of fluid column, air embolism, myocardial infarction, cardiogenic shock and low blood pressure requiring intervention.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4.The steerable guide catheter (sgc) was advanced to the patient¿s left atrium (la) and the dilator was pulled out without checking for back bleeding.It was noted that the water level in the sgc had dropped.Considering the possibility that the soft tip of the sgc was hitting the wall somewhere, the physician pulled the sgc back and performed aspiration again, however, the column could not be completely filled with blood.The sgc was removed from the stabilizer and lowered below the heart level and the sgc hemostatic valve was filled with blood.At this time, air entered the la from the sgc.The electrocardiogram (ecg) showed st elevation and the patient was diagnosed with myocardial infarction.In addition, the patient went into cardiogenic shock and the patient¿s systolic blood pressure decreased to about 60mmhg.Chest compressions were started, noradrenaline medication was administered, and the anesthesiologist started a pressure booster by inserting a pigtail catheter through the left femoral and connected it to the anesthesia machine for oxygenation.The patient recovered and one mitraclip was implanted reducing the final mr to a grade of 1.After awakening from anesthesia, it was confirmed that the patient did not experience any cerebral infarction.There was no clinically significant delay in the procedure and no adverse patient sequelae.No additional information was provided.

Manufacturer Narrative

The device was not returned.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no similar complaints from the lot.All available information was investigated and a cause for the reported leak in this complaint could not be determined.The reported air embolism, hypotension and electrocardiogram (ekg) changes, myocardial infarction and cardiogenic shock appear to be related to the procedural conditions associated with the steerable guide catheter (sgc) leak.Air embolism, hypotension, myocardial infarction and cardiogenic shock are listed in the instructions for use (ifu) as known possible complications associated with mitraclip procedures.The unexpected medical interventions and medication required were a result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design or labeling.

• Brand Name: G4 STEERABLE GUIDING CATHETER
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 13722096
• MDR Text Key: 286942691
• Report Number: 2024168-2022-02474
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K190167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2022
• Device Model Number: N/A
• Device Catalogue Number: SGC0705
• Device Lot Number: 10902R105
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2021
• 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
• Patient Age: 74 YR
• Patient Sex: Female