MAUDE Adverse Event Report: ABBOTT MEDICAL MITRACLIP¿ G4 STEERABLE GUIDE CATHETER (MDR); CATHETER, STEERABLE

Catalog Number SGC0701

Device Problem Leak/Splash (1354)

Patient Problems Air Embolism (1697); Low Blood Pressure/ Hypotension (1914)

Event Date 11/29/2023

Event Type  Injury  

Event Description

It was reported that a patient presented with grade 4 functional mitral regurgitation (mr) for a mitraclip procedure.The steerable guide catheter crossed the septum successfully.When the dilator was retracted approximately 5 cm, the patient suffered a large drop in blood pressure.Resuscitative measures were performed including cardiopulmonary resuscitation (cpr).The patient sustained a cracked rib due to cpr, so the procedure was abandoned.The patient was reported stable.The physician's opinion was that there was an air embolism.There was no evidence of air in the anatomy on imaging.When the sgc was removed, it was tested on the back table.The sgc could successfully be re-prepped and held fluid column.The physician thought the air may be related to the rotating hemostatic valve on the dilator, although everything was performed per ifu.There was no evidence of effusion during or after the procedure.No additional information was provided.

Manufacturer Narrative

All available information was investigated and the reported leak was not confirmed via returned device analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no other complaints reported from this lot.The investigation was unable to determine a cause for the reported leak.The reported air embolism and subsequent hypotension appear to be related to the reported leak.Air embolism and hypotension are listed in the instructions for use as known possible complications associated with the mitraclip procedures.The reported unexpected medical intervention was a result of case specific circumstance.There is no indication of a product issue with respect to manufacture, design, or labeling.

• Brand Name: MITRACLIP¿ G4 STEERABLE GUIDE CATHETER (MDR)
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18376692
• MDR Text Key: 331179808
• Report Number: 2135147-2023-05664
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648231025
• UDI-Public: 08717648231025
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SGC0701
• Device Lot Number: 30830R1017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR