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 Codes	Air Embolism (1697); Non specific EKG/ECG Changes (1817)
Date of Event	06/08/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Abbott is issuing this important field safety corrective action for the amplatzer steerable delivery sheath (asds) due to the hemostasis valve.A complaint trend has been observed on the asds device related to air ingress.Fluid is managed via a hemostasis valve on the proximal end of the handle.The design of the hemostasis valve component is intended to facilitate blood management by minimizing blood return through the device but is not designed for air management while instead relying on the user to practice optimal fluid management technique.The hemostasis valve has been determined to be sensitive to certain patient physiological conditions and use scenarios resulting in a higher-than-expected rate of actual and potential air embolus experiences in a limited number of user accounts.The asds integrated hemostasis valve design and procedural use allow for air to ingress when optimal air management techniques are not adhered to by physicians.Although this inherent design limitation is included as a precaution within the ifu, the extent to which patient and physician use factors can exacerbate the likelihood of an air ingress event have allowed for the actual occurrence rate to exceed the expected rate.The scope of the field safety corrective action will include all customers who have received product with remaining shelf-life.The capa investigation has confirmed that the asds integrated hemostasis valve design and procedural use allow for air to ingress when optimal air management techniques are not adhered to by physicians.Although this inherent design limitation is included as a precaution within the ifu, the extent to which patient and physician use factors can exacerbate the likelihood of an air ingress event have allowed for the actual occurrence rate to exceed the expected rate.See attached list of mdr reports already submitted that are included in the field safety corrective action.
Event or Problem Description
Abbott is issuing this important field safety corrective action for the amplatzer steerable delivery sheath (asds) due to the hemostasis valve.A complaint trend has been observed on the asds device related to air ingress.Fluid is managed via a hemostasis valve on the proximal end of the handle.The design of the hemostasis valve component is intended to facilitate blood management by minimizing blood return through the device but is not designed for air management while instead relying on the user to practice optimal fluid management technique.The hemostasis valve has been determined to be sensitive to certain patient physiological conditions and use scenarios resulting in a higher-than-expected rate of actual and potential air embolus experiences in a limited number of user accounts.

• 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#3007113487; 177 county road b east; st. paul MN 55117 1789
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 17114636
• Report Number: 2135147-2023-02548
• Device Sequence Number: 6649473
• Product Code: DQY
• UDI-Device Identifier: 05415067036025
• UDI-Public: 05415067036025
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 06/12/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: ASDS-14F-075
• Device Catalogue Number: ASDS-14F-075
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/08/2023
• Initial Report FDA Received Date: 06/12/2023
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2135147-6/8/23-001-R
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown