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); Low Blood Pressure/ Hypotension (1914)

Event Date 10/28/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

This report is filed due to the steerable guide catheter air leak and possible air embolus.It was reported that on (b)(6) 2020, the patient presented with mixed mitral regurgitation (mr) grade 4.The steerable guide catheter (sgc) was placed without issue and the first mitraclip was successfully implanted.Using the same sgc, another clip delivery system advanced without an issue or resistance observed, when air was observed in the sgc valve.The patient's blood pressure dropped.Per physician, an air embolus was possible.Epinephrine was provided and the event resolved.There was no air observed in the clip delivery system (cds).The same sgc remained in place and the same cds mitraclip was successfully implanted.The mr had been reduced to grade 1.The patient remained in stable condition.No additional information was provided regarding this issue.

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 similar complaint reported from this lot.It should be noted that the reported patient effects of emboli (air) and hypotension as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.All available information was investigated and a conclusive cause for the reported leak could not be determined.However, air embolism and hypotension were due the reported leak.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: 10854522
• MDR Text Key: 216839127
• Report Number: 2024168-2020-09626
• 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: 01/04/2021

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: 07/09/2021
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 00710U235
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/28/2020
• Initial Date FDA Received: 11/17/2020
• Supplement Dates Manufacturer Received: 12/15/2020
• Supplement Dates FDA Received: 01/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CLIP DELIVERY SYSTEM; IMPLANTED MITRACLIP X1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Weight: 61