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

Catalog Number SGC0702

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

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

Event Date 06/24/2022

Event Type  Injury  

Manufacturer Narrative

The device was retained by hospital and not returning for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

This is filed for a vasovagal reaction that required cardiopulmonary resuscitation (cpr) and medication.It was reported that on 6/24/2022, the patient presented with grade 3-4 mixed mitral regurgitation (mr), and a prolapse flail on the posterior medial lateral (pml).After insertion of the mitraclip steerable guide catheter (sgc) into the anatomy, the patient experienced a vasovagal reaction, resulting in hypotension and decreased heart rate, requiring cardiopulmonary resuscitation (cpr) for approximately 2 minutes.Catecholamine was also administered to stabilize the patient.There was no device malfunction.The procedure was completed with both clips implanted, reducing mr to <1.The patient left the cath lab in stable condition.No additional information was provided regarding this issue.

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 the reported event.The reported patient effects of hypotension and bradycardia are listed in the mitraclip g4 system instructions for use (ifu) as known possible complications associated with mitraclip procedures.Based on the information reviewed, the reported bradycardia and hypotension appeared to be related to patient conditions.The reported unexpected medical intervention and medication were 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 MEDICAL; 5050 nathan lane n; plymouth MN 55442 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442-4628 ; 6517565400
• MDR Report Key: 15020073
• MDR Text Key: 295950042
• Report Number: 2024168-2022-07721
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 09/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/15/2023
• Device Catalogue Number: SGC0702
• Device Lot Number: 20216R140
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2022
• 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: STEERABLE GUIDE CATHETER
• Patient Outcome(s): Required Intervention