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

Catalog Number SGC0702

Device Problems Difficult or Delayed Positioning (1157); Unintended Movement (3026)

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

Event Date 10/18/2021

Event Type  malfunction  

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 2. It was noted restricted posterior, large left atrium appendix, and short septal lateral diameter. Imaging of the clip was difficult due to the complex anatomy. The steerable guide catheter (sgc) crossed the septum pointing towards anterior and the guide and dilator were then guided towards posterior by the wire which was placed in the left upper pulmonary vein. Therefore the tip of the dilator was a bit deflected. The sgc was advanced to the mitral valve; however, after rotating the handle clockwise, the guide tip could not curve more posterior. The cds was the advancing and the clip exited the guide, but the clip was touching the lateral wall. Therefore, the guide tip was retracted close to the septum the clip was not visible when the cds was advanced into straddling position. When trying to steer down with maximum guide retraction and a bit under straddled. M knob was removed, and an attempt was made to under straddle more, but failed. The + knob of the sgc was applied; however the tip slipped slightly to the right atrium. The cds could not be positioned. The procedure was to be aborted, but the clip was not able to be retracted. Each time the cds was retracted, the lateral wall was coming closer to the septum. The blood pressure dropped very low, and a pericardial effusion was observed severely impacting the hearts dialostic capacities. The pe was treated with pericardiocentesis. The blood pressure improved, but additional blood transfusion was needed. The cds was able to be removed into the guide, and both the sgc and cds were removed from the patient. There was visible damage to the lateral left atrium wall. The procedure was aborted and the patient remained hospitalized and was transferred to heart surgery. Mitral valve and tricuspid valve repair was successfully performed. No clips were implanted, and mr is 2. There was no clinically significant delay in the procedure. No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event. Additionally, a review of the complaint history identified no similar complaints from the lot. All available information was investigated and the reported unintended movement of the steerable guide catheter (sgc) appears to be related to user technique/procedural circumstances. The reported difficult positioning appears to be related to patient conditions. There is no indication of a product issue with respect to manufacture, design or labeling. The additional clip delivery system referenced in describe event or problem and concomitant medical products is filed under a separate medwatch report number.

• 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: 12778810
• MDR Text Key: 285331739
• Report Number: 2024168-2021-10146
• 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

• Type of Report: Initial
• Report Date: 11/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: SGC0702
• Device Lot Number: 10630R449
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2021
• 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: 11/09/2021 Patient Sequence Number: 1

Treatment

CLIP DELIVERY SYSTEM