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

Catalog Number SGC0702

Device Problems Unintended Movement (3026); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/19/2021

Event Type  malfunction  

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.The additional device referenced is filed under a separate medwatch report number.

Event Description

This is filed to report unintended movement.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4.On (b)(6) 2021, the steerable guide catheter (sgc) was advanced to the mitral valve; however, advancement was difficult due to the high tortuosity of the femoral vein and the sgc was advanced too much in the left atrium.After the sgc crossed the septum, the clip delivery system (cds) was advanced through the sgc, but then the sgc and clip moved unintentionally.Then the clip went through the left atrium wall and came outside the heart wall, causing a clinically significant delay in the procedure.The procedure was aborted and was converted to surgery which resulted in the patient to remain hospitalized longer.The clip was extracted prior to surgery.Then the hole of the left atrium wall was patched and a drainage was placed.The patient arterial blood pressure was very low and a long massage was required to recover the patient.No clips were implanted, and mr is 4.On (b)(6) 2021, the patient died due to decompensation of organs following the surgery performed.No other information was provided.

Event Description

Subsequent to the initially filed report, the following information was received: the steerable guide catheter (sgc) and clip delivery system (cds) did not unintentionally move; however, the user inadvertently maneuvered both the sgc and cds too far in the left atrium.No other 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.A review of lot-specific similar complaints identified no other complaints reported from this lot.Based on available information, the reported difficulty advancing the steerable guide catheter appears to be due to challenging patient anatomy.There is no indication of 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: 12983802
• MDR Text Key: 282116405
• Report Number: 2024168-2021-11477
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 01/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/12/2022
• Device Catalogue Number: SGC0702
• Device Lot Number: 10712R353
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2021
• 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
• Treatment: CLIP DELIVERY SYSTEM.
• Patient Age: 84 YR
• Patient Sex: Female