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

Model Number SGC0301

Device Problem Leak/Splash (1354)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 01/24/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

This is filed for leak.It was reported that the procedure was performed to treat degenerative mitral regurgitation (mr) of grade 4+.The steerable guide catheter (sgc) was prepared per instructions for use (ifu) and no issues were noted.The transseptal puncture was performed without issue and the sgc was advanced into the patient anatomy.The clip delivery system (cds) was advanced; however, due to the transseptal puncture location, the cds was unable to be correctly positioned and was removed without issue.The sgc was removed and the transseptal puncture was performed in a second location.The sgc was re-flushed to re-insert and the dilator was re-inserted; however, the fluid column was lost and the device was not inserted into the patient anatomy.The decision was made to discontinue use of the device.As the transseptal puncture was noted to be in a sub-optimal location, the procedure was aborted.The decision was made to re-schedule the procedure at a later date.There were no adverse patient effects and no clinically significant delay.On (b)(6) 2020, the patient died of causes related to renal hepatic failure and unrelated to the mitraclip device.No additional information was provided.

Manufacturer Narrative

The device was returned and investigated.The reported steerable guide catheter (sgc) leak/splash (loss of fluid column) was not confirmed as no leak was observed.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history did not indicate a lot-specific product issue.All available information was investigated and a cause for the reported leak in this complaint could not be determined.There is no indication of a product issue with respect to manufacture, design or labeling.H6: patient coding - code 2199 removed.

Event Description

Subsequent to the initial 30-day medwatch report, additional clarification was received, which indicated that the event occurred outside of the anatomy.No additional information was provided.

• 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: 9718008
• MDR Text Key: 179717513
• Report Number: 2024168-2020-01551
• 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: 03/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/27/2020
• Device Model Number: SGC0301
• Device Catalogue Number: SGC0301
• Device Lot Number: 91028U141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2020
• Initial Date Manufacturer Received: 01/24/2020
• Initial Date FDA Received: 02/17/2020
• Supplement Dates Manufacturer Received: 02/28/2020
• Supplement Dates FDA Received: 03/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CLIP DELIVERY SYSTEM
• Patient Age: 91 YR