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

Catalog Number SGC0302

Device Problems Crack (1135); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/02/2020

Event Type  Injury  

Manufacturer Narrative

The device was returned.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

This is being filed to report leak, crack, and medical intervention.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4.It was noted sub-optimal transseptal puncture.The first clip was successfully deployed.Then when advancing the second clip delivery system (cds) into the steerable guide catheter (sgc), loss of fluid column was observed and air entered the outside part of the sgc.Additional aspirations were performed and both the cds and sgc were removed from the patient.The devices were inspected and it was observed that the hemostatic valve of the sgc was cracked which resulted in air leakage, and the clip would not open.Therefore, the procedure continued with a new sgc and a new cds.Two clips were implanted, reducing mr to 1-2.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

All available information was investigated and the reported steerable guide catheter (sgc) leak (loss of fluid column) was confirmed and the silicone valve was observed to be torn instead of crack.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no similar incidents reported from this lot.All available information was investigated, and the reported leak appears to be related to the observed torn in silicone valve.However, a cause for how and when the tear occurred cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.The additional device referenced in b5 is being filed under separate medwatch report.

• 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: 9862900
• MDR Text Key: 187407128
• Report Number: 2024168-2020-02762
• Device Sequence Number: 1
• Product Code: DRA
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 04/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/17/2020
• Device Catalogue Number: SGC0302
• Device Lot Number: 91118U134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2020
• Date Manufacturer Received: 04/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 1 IMPLANTED MITRACLIP; CLIP DELIVERY SYSTEM; STEERABLE GUIDE CATHETER
• Patient Outcome(s): Required Intervention