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

Model Number SGC0701

Device Problem Leak/Splash (1354)

Patient Problems Air Embolism (1697); Cardiac Enzyme Elevation (1838); Low Blood Pressure/ Hypotension (1914)

Event Date 10/28/2020

Event Type  Injury  

Manufacturer Narrative

The device will not be returned for evaluation; the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

This is filed to report the steerable guide catheter leak.It was reported this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with a grade of 4+.After insertion of the steerable guide catheter (sgc), air bubbles were seen in the aorta.St elevation was noted and the patient became hypotensive.Additional heparin was administered, and the aspiration was performed.The patient was stabilized.The procedure continued with the same sgc.No damage was observed on the sgc.One clip was implanted, and mr was reduced to <1.It is speculated the air came through the open tuohy on the dilator, but no air was seen in the device.The patient remained stable.No additional information was provided.

Manufacturer Narrative

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 complaint reported from this lot.The reported patient effects of emboli (air), myocardial infarction and hypotension as listed in the mitraclip system instructions for use (ifu), are a known possible complications associated with mitraclip procedures.All available information was investigated and a conclusive cause for the reported leak, st-elevation and hypotension could not be determined.However, air embolism was due the reported leak.The reported additional therapy/non-surgical treatment and treatment with medication appears to be due to case specific circumstances as additional heparin was administered and aspiration was performed to stabilize the patient.There is no indication of a product issue with respect to manufacture, design or labeling.

• Brand Name: G4 STEERABLE GUIDING CATHETER
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10865148
• MDR Text Key: 217094608
• Report Number: 2024168-2020-09725
• 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: 12/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/29/2021
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 00730U141
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/28/2020
• Initial Date FDA Received: 11/18/2020
• Supplement Dates Manufacturer Received: 12/10/2020
• Supplement Dates FDA Received: 12/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention