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

Catalog Number SGC0702

Device Problems Difficult or Delayed Positioning (1157); Leak/Splash (1354)

Patient Problems Air Embolism (1697); Low Blood Pressure/ Hypotension (1914)

Event Date 02/04/2022

Event Type  Injury  

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. Additionally, a review of the complaint history identified no other complaints from the lot. All information was investigated, and the difficult positioning associated with difficulty crossing the septum with the steerable guide catheter (sgc) appears to be related to the suboptimal transseptal puncture and therefore, related to patient conditions. However, a cause for the reported sgc leak cannot be determined. The reported air embolism resulting in hypotension appears to be related to the procedural conditions associated with the sgc leak. Air embolism and hypotension are listed in the instructions for use (ifu) as known possible complications associated with mitraclip procedures. The unexpected medical intervention was a result of case-specific circumstances. There is no indication of a product issue with respect to manufacture, design or labeling.

Event Description

This is filed to report leak, air embolism and medical intervention. It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4. It was noted suboptimal transseptal puncture. The steerable guide catheter (sgc) crossed the septum; however, crossing the septum was difficult due to the suboptimal transseptal puncture and air was observed in the left atrium. Additionally, the patient's blood pressure dropped. Therefore, the 3-way stopcock was opened and closed. No new air was observed. Medication was administered to treat the blood pressure drop and stabilize the patient. The procedure continued, and a clip delivery system (cds) was advanced through the sgc. However, due to an aorta hugger, the cds was difficult to orient above the leaflets. Troubleshooting was unsuccessful, therefore a decision was made to make another transseptal puncture. The septum was punctured 2 cm above the fossa ovalis and the procedure continued. The cds was advanced to the mitral valve, and the clip was deployed. One clip was implanted, reducing mr to 1. There was no clinically significant delay in the procedure. 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: 13578132
• MDR Text Key: 287112207
• Report Number: 2024168-2022-01845
• 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: 02/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: SGC0702
• Device Lot Number: 10909R256
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2021
• 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: 02/22/2022 Patient Sequence Number: 1