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

Catalog Number SGC0705

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

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

Event Date 05/19/2021

Event Type  Injury  

Manufacturer Narrative

The device was not returned for analysis.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 the available information, causes for the hypotension and bradycardia could not be determined.Additionally, hypotension and bradycardia are listed in the instructions for use as known possible complications associated with mitraclip procedures.The reported medication required, delay to treatment and unexpected medical intervention were the results of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design, or labeling.The additional mitraclip device referenced is filed under separate medwatch report number.

Event Description

This is filed to report bradycardia.It was reported this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4.Patient had a pericardial effusion, low heartbeat and had been on an intra-aortic balloon pump (iabp) for several days prior to the procedure.The steerable guide catheter (sgc) was inserted and advanced into the left atrium (la) without issues.However, roughly 3-5 minutes after the sgc reached the la, the patient blood pressure decreased, and bradycardia occurred.Chest compressions were performed, and adrenaline was administered, resulting in a clinically significant delay in the procedure.The patient was able to be stabilized; therefore, the physician decided to continue with the procedure.An ntw clip was inserted and grasping was performed at a2/p2.After the leaflets were grasped, regurgitation was observed on the proximal part of the clip.It was suspected that the clip had caused damage to leaflets; therefore, the clip was removed and replaced with an xtw clip.This clip was successfully implanted, reducing mr to a grade of 1.There was no clinically significant delay in the procedure.No additional information was provided.

• 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: 11984373
• MDR Text Key: 255773660
• Report Number: 2024168-2021-04926
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/08/2022
• Device Catalogue Number: SGC0705
• Device Lot Number: 10109U151
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2021
• 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: 81 YR