MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER STEERABLE DELIVERY SHEATH; CATHETER, PERCUTANEOUS

Model Number	ASDS-14F-075
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	Air Embolism (1697)
Date of Event	11/23/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on (b)(6) 2022, an unknown device was selected for implant using an unknown sized amplatzer steerable sheath.During procedure, air embolism in the sheath was observed.The air embolism was "very tiny and healed itself".No intervention was required and no adverse events were reported.No patient consequences were reported.
Event or Problem Description
Subsequent to the previously filed report, additional information was received: it was reported that there were only air bubbles seen in the loader.Intervention occurred by back bleeding.
Additional Manufacturer Narrative
An event of air embolism was reported.Information from field indicated that there were only air bubbles seen in the loader and that the air embolism healed itself.A returned device inspection, to rule out any device-related causes, could not be performed as the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.G1: manufacturing site updated to 2135147.H6: code 2199 was removed.
Event or Problem Description
It was reported that on (b)(6) 2022, an unknown device was selected for implant using an unknown sized amplatzer steerable sheath.During procedure, air embolism in the sheath was observed.The air embolism was "very tiny and healed itself." there were only air bubbles seen in the loader.Intervention occurred by back bleeding.No intervention was required and no adverse events were reported.No patient consequences were reported.

• Brand Name: AMPLATZER STEERABLE DELIVERY SHEATH
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG# 2135147; 5050 nathan ln n; plymouth MN 55442 1789
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16043189
• Report Number: 2135147-2022-02707
• Device Sequence Number: 12328784
• Product Code: DQY
• UDI-Device Identifier: 05415067036025
• UDI-Public: 05415067036025
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K212026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/02/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: ASDS-14F-075
• Device Catalogue Number: ASDS-14F-075
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/01/2022
• Supplement Date Received by Manufacturer: 01/31/2023; 05/02/2023
• Initial Report FDA Received Date: 12/23/2022
• Supplement Report FDA Received Date: 02/04/2023; 05/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown