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

Catalog Number SGC0301

Device Problems Break (1069); Leak/Splash (1354); Improper or Incorrect Procedure or Method (2017); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/08/2019

Event Type  Injury  

Manufacturer Narrative

The device was reportedly discarded and will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.(b)(4).

Event Description

This will be filed on steerable guide catheter for hemostasis valve break and air leak.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4+ and a posterior leaflet flail.The steerable guide catheter (sgc) was advanced and while up against the lateral wall of the left atrium, as the dilator was being taken out and the wire out of the sgc, a vacuum was created and air was being pulled into the device.Aspiration was done.While attempting to remove the clip delivery system (cds) from the anatomy, there was difficulty getting the clip into the introducer while in the left atrium.Troubleshooting attempts were done successfully getting the clip into the introducer.As the introducer was retracted during aspiration, prior to coming out the hemostasis valve, it was noted that the hemostasis valve was over stretched and tore.The devices and undeployed clip were removed and replaced with a new device.No air entered the anatomy.Post procedure mr was reduced to 2+.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.

Manufacturer Narrative

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.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 incidents reported from the lot.It should be noted that the mitraclip instructions for use, states: avoid contacting tissue or creating a vacuum in the guide lumen.The investigation determined the reported leak to be related to the user error (improper or incorrect procedure or method) of advancing the sgc up against the lateral wall of the left atrium, resulting in a vacuum being created, and air entering the device during dilator/guide wire removal.The tear in the guide (silicone) valve appears to be due to the procedural circumstances of difficult cds retraction into the clip introducer.There is no indication of a product issue with respect to manufacture, design or labeling.Correction - removed device code 1069.

• 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: 9342974
• MDR Text Key: 167126782
• Report Number: 2024168-2019-13737
• 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: 12/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2020
• Device Catalogue Number: SGC0301
• Device Lot Number: 90713U224
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CLIP DELIVERY SYSTEM
• Patient Outcome(s): Required Intervention
• Patient Age: 89 YR
• Patient Weight: 89