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

Catalog Number SGC0301

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 12/11/2019

Event Type  malfunction  

Manufacturer Narrative

Exemption number e2019001.The device was reported to be discarded.Investigation is not yet completed.A follow-up report will be submitted with all additional relevant information.

Event Description

This is filed to report during preparation the steerable guide catheter a leak was noted.It was reported that this was a mitraclip procedure to treat mitral regurgitation.During preparation of the steerable guide catheter (sgc), the sgc failed to hold column.The sgc was not used and never entered the patient anatomy.There was no patient involvement and no clinically significant delay in the procedure reported due to the device.No additional information was provided.

Manufacturer Narrative

G9: 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 did not identify any similar incidents.All available information was investigated and a definitive cause for the reported leak (loss of fluid column) in this incident could not be determined.There is no indication of a product issue with respect to manufacture, design or labeling.

• 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: 9539075
• MDR Text Key: 178156549
• Report Number: 2024168-2020-00047
• 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: 01/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/06/2020
• Device Catalogue Number: SGC0301
• Device Lot Number: 90906U221
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1