MAUDE Adverse Event Report: ABBOTT VASCULAR STEERABLE GUIDE CATHETER; VALVE REPAIR

Catalog Number SGC0301

Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Air Embolism (1697)

Event Date 07/23/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The customer reported the device was discarded.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

This is being filed to report air embolism and intervention.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4.A clip delivery system (cds) was advanced to the mitral valve, and the clip was deployed.However, the physician inadvertently did not remove the clip introducer from the steerable guide catheter (sgc).Then a second cds was advanced with the same sgc, and the clip was deployed.At the end of the procedure, the sgc was being removed when air was observed in the left atrium.Aspirations was performed, and the air was removed.The patient is stable.Two clips were implanted, reducing mr to 1.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to the reported lot.Based on the information reviewed, the reported embolism is a result of the procedural conditions.It should be noted that as per the instructions for use warning states: do not remove the tip of the cds from the guide without removing the clip introducer simultaneously.Failure to remove the clip introducer simultaneously may result in air embolism.The improper or incorrect use appears to be related to the user/ physician inadvertently did not remove the clip introducer from the sgc.There is no indication of a product quality issue with respect to manufacture, design or labeling; therefore, no product-related corrective action will be implemented in this case.Exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.

• Brand Name: STEERABLE GUIDE CATHETER
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 8894114
• MDR Text Key: 154313070
• Report Number: 2024168-2019-10844
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648216824
• UDI-Public: 08717648216824
• Combination Product (y/n): N
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/09/2020
• Device Catalogue Number: SGC0301
• Device Lot Number: 90410U141
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TWO CLIP DELIVERY SYSTEMS; TWO CLIP DELIVERY SYSTEMS
• Patient Outcome(s): Required Intervention
• Patient Age: 96 YR
• Patient Weight: 80