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 Arrhythmia (1721); Bradycardia (1751); Low Blood Pressure/ Hypotension (1914); Perforation (2001)

Event Date 12/17/2021

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 will be filed to report after steerable guide catheter was placed, the patient experienced hypotension, bradycardia requiring medical intervention.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with grade 4+.After the steerable guide catheter (sgc) was inserted into the left atrium, aspiration was performed as the dilator and guide wire were removed.The patient had a sudden drop in blood pressure, bradycardia, sinus arrest [arrhythmia] and a smoke like observation [atrial perforation] in echocardiogram was seen in the left atrium.The patient hemodynamics were impaired.Intra-aortic balloon pump (iabp) and a catheter pacing were placed.Anesthesia management was performed stabilizing hemodynamics.Then, the clip delivery system (cds) was advanced to the mitral valve and the clip was safely deployed, reducing mr to 1+.The procedure was completed with stable hemodynamics.In the physician¿s opinion, the hemodynamic impairment was due to 30 cc of blood that was pulled out from the left atrium during aspiration.No additional information was provided.

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 will be filed to report after steerable guide catheter was placed, the patient experienced hypotension, bradycardia requiring medical intervention.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with grade 4+.After the steerable guide catheter (sgc) was inserted into the left atrium, aspiration was performed as the dilator and guide wire were removed.The patient had a sudden drop in blood pressure, bradycardia, sinus arrest [arrhythmia] and a smoke like observation [atrial perforation] in echocardiogram was seen in the left atrium.The patient hemodynamics were impaired.Intra-aortic balloon pump (iabp) and a catheter pacing were placed.Anesthesia management was performed stabilizing hemodynamics.Then, the clip delivery system (cds) was advanced to the mitral valve and the clip was safely deployed, reducing mr to 1+.The procedure was completed with stable hemodynamics.In the physician¿s opinion, the hemodynamic impairment was due to 30 cc of blood that was pulled out from the left atrium during aspiration.No additional information was provided.

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 available information, the reported arrhythmia was due to procedural conditions.The reported bradycardia and hypotension appear to be cascading effects of the arrhythmia.The reported patient effects of arrhythmia and hypotension as listed in the mitraclip system instructions for use are known possible complications associated with mitraclip procedures.The reported unexpected medical intervention and medication required were results of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design or labeling.H6.Health effect - clinical code 2001 removed.

• 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: 13212362
• MDR Text Key: 285504715
• Report Number: 2024168-2022-00326
• 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: 02/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/21/2022
• Device Catalogue Number: SGC0705
• Device Lot Number: 10622R157
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2021
• 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
• Patient Sex: Male
• Patient Weight: 58 KG