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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Air Embolism (1697); Bradycardia (1751); Low Blood Pressure/ Hypotension (1914)

Event Date 05/25/2022

Event Type  Injury  

Event Description

This is filed to report air entering the patient requiring medical 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 inserted in the patient and the clip delivery system (cds) was advanced to the left atrium.At this time, the patient¿s blood pressure and heart rate lowered.Due to the patient¿s symptoms, it was suspected that air entered the patient¿s body.Medication was given and the patient was stabilized.The procedure continued and the mitraclip was successfully implanted in the patient reducing the final mr to a grade of 2.There was no clinically significant delay in the procedure and no adverse patient sequelae.The physician had doubt about the air management with the 3-way stopcocks.No additional information was provided.

Manufacturer Narrative

The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

The device was returned for analysis.Although there was no device malfunction reported, it was visually inspected as a conservative measure and no device damage/issues were identified.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Based on available information, the cause of the reported hypotension and bradycardia could not be determined.A cause of the suspected air embolism also could not be determined.The reported patient effects of embolism, hypotension and bradycardia as listed in the mitraclip system instructions for use (ifu) are known possible complications associated with mitraclip procedures.The reported medication required was a result of case-specific circumstances.There is no indication of a product quality 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: 14698526
• MDR Text Key: 294129827
• Report Number: 2024168-2022-06420
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 07/18/2022

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
• Device Expiration Date: 01/24/2023
• Device Model Number: N/A
• Device Catalogue Number: SGC0702
• Device Lot Number: 20125R346
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/25/2022
• Initial Date FDA Received: 06/15/2022
• Supplement Dates Manufacturer Received: 06/30/2022
• Supplement Dates FDA Received: 07/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2022
• 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
• Treatment: CLIP DELIVERY SYSTEM
• Patient Outcome(s): Required Intervention