MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER STEERABLE DS; 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	10/24/2022
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 amplatzer steerable delivery sheath was chosen for use.The dilator and sheath was flushed using the extension tubing.A stopcock was used to attach the saline syringe to the sheath.Once flushed a pressurized saline bag was attached to the extension tubing of the sheath.The sheath was advanced over the non-abbott (versacross) wire into the left atrium.The dilator was removed and he pigtail was advanced over the wire into the left atrium.The wire was removed, and the left atrial appendage was engaged with the pigtail.The operator then injected contrast with a manifold.Shortly after, slight st elevations were observed, and it was believed to have come from the bubbles.The procedure was paused for 5 minutes to monitor the electrocardiogram.During this time the st elevations diminished back to normal sinus rhythm by the 5 minute marker.No medication or intervention was required.There no conclusive evidence on what caused the bubbles.The patient status was reported as stable.
Additional Manufacturer Narrative
An event of air embolism after injecting contrast into the patient was reported.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.No other complaints were reported on this batch.A returned device assessment could not be performed as the device was not returned for analysis.Nformation from the field indicated that the physician had aspirated the sheath prior to the injection of the contrast and the air embolism, against the instructions for use.There is no indication of a product quality issue with regards to manufacture, design, or labeling.
Event or Problem Description
It was reported that on (b)(6) 2022, an amplatzer steerable delivery sheath was chosen for use.The dilator and sheath was flushed using the extension tubing.A stopcock was used to attach the saline syringe to the sheath.Once flushed a pressurized saline bag was attached to the extension tubing of the sheath.The sheath was advanced over the non-abbott (versacross) wire into the left atrium.The dilator was removed and he pigtail was advanced over the wire into the left atrium.The wire was removed, and the left atrial appendage was engaged with the pigtail.The operator then injected contrast with a manifold.Shortly after, slight st elevations were observed, and it was believed to have come from the bubbles.The procedure was paused for 5 minutes to monitor the electrocardiogram.During this time the st elevations diminished back to normal sinus rhythm by the 5 minute marker.No medication or intervention was required.There no conclusive evidence on what caused the bubbles.The patient status was reported as stable.Subsequent to the previously filed report, additional information was received that the physician elected to perform a quick aspiration prior to injecting contrast despite an abundance of caution not to perform any aspiration.

• Brand Name: AMPLATZER STEERABLE DS
• 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: 15845866
• Report Number: 2135147-2022-02166
• Device Sequence Number: 12490059
• Product Code: DQY
• UDI-Device Identifier: 05415067036025
• UDI-Public: 05415067036025
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 02/16/2023

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 Expiration Date: 03/31/2023
• Device Model Number: ASDS-14F-075
• Device Catalogue Number: ASDS-14F-075
• Device Lot Number: 8428366
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/24/2022
• Supplement Date Received by Manufacturer: 02/15/2023
• Initial Report FDA Received Date: 11/22/2022
• Supplement Report FDA Received Date: 02/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2022
• 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: Other
• Patient Age: 70 YR
• Patient Sex: Male