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

Catalog Number SGC0705

Device Problems Difficult to Remove (1528); Unintended Movement (3026)

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

Event Date 01/17/2022

Event Type  malfunction  

Manufacturer Narrative

The additional device referenced are filed under separate medwatch report number. 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. Additionally, a review of the complaint history identified no similar complaints reported from this lot. The investigation was unable to determine a cause for the reported difficult to remove (cds from sgc) cannot be determined. The reported unintended movement of the sgc appears to have been a result of the reported difficult to remove. There is no indication of a product issue with respect to manufacture, design or labeling.

Event Description

This is being filed to report the unintended movement of the device and difficulty removing the cds. It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 2-3. When advancing the steerable guide catheter (sgc) to the left atrium (la), it advanced too deep and went near the pulmonary vein (pv) entrance. Bleeding was noted from the trachea. Positive end expiratory pressure (peep) was applied and the procedure continued. Per the physician, the bleeding from the trachea was not caused by the sgc. The clip delivery system (cds) was advanced however resistance was met. Echo imaging noted the sgc seems to be missing in the right atrium (ra) even though cds is tried to be replaced. Resistance was met pulling the cds into the sgc; however when the cds was pulled on, the tension was released and the sgc re-entered the la. The cds was removed from the patient. A new cds was used and the clip implanted, reducing mr to 1. There was no clinically significant delay in the procedure and no adverse patient effects. 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: 13388843
• MDR Text Key: 284708218
• Report Number: 2024168-2022-00972
• 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

• Type of Report: Initial
• Report Date: 01/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: SGC0705
• Device Lot Number: 10805R233
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 01/28/2022 Patient Sequence Number: 1

Treatment

CLIP DELIVERY SYSTEM