MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP G4 STEERABLE GUIDE CATHETER; CATHETER, STEERABLE

Catalog Number SGC0701

Device Problems Difficult to Flush (1251); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/13/2019

Event Type  malfunction  

Manufacturer Narrative

Exemption number e2019001.The device was received, but the investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The clip delivery system that was used on this patient is being filed under a separate medwatch report.

Event Description

This is filed to report the air in the device.It was reported that this was a mitraclip procedure in the patient with grade 4 degenerative mitral regurgitation (mr).The steerable guide catheter (sgc) was advanced into the patient.When the physician inserted the sgc and tried to aspirate per the standard instructions, it took much longer than expected to aspirate.The tip of the sgc was confirmed on imaging to be free of any structures.Air was entering the sgc as seen by air in the fluid column but no air was introduced into the patient.It did not take more force to aspirate from the sgc, but it did take longer than usual.The same sgc was used to complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.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 returned device analysis did not confirm the reported leak/splash as the device passed the leak test and no loss of fluid column as observed.The sgc could also be flushed without any issue therefore the reported difficult to flush also could not be confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history did not identify a lot specific issue.Based on the information available, a definite cause for the reported leak/splash (loss of fluid column during procedure) and difficult to flush could not be determined.There is no indication of product quality issue with respect to manufacture, design or labeling.

• Brand Name: MITRACLIP G4 STEERABLE GUIDE CATHETER
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9405116
• MDR Text Key: 177761962
• Report Number: 2024168-2019-14069
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648231025
• UDI-Public: 08717648231025
• Combination Product (y/n): N
• PMA/PMN Number: K190167
• 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: 01/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/30/2020
• Device Catalogue Number: SGC0701
• Device Lot Number: 91001U209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2019
• Date Manufacturer Received: 12/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Weight: 49