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

Model Number	ASDS-14F-075
Medical Device Problem Codes	Fluid/Blood Leak (1250); Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2023
Type of Reportable Event	Malfunction
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) 2023, a 14f amplatzer steerable delivery sheath was chosen for an left atrial appendage implant procedure.During device preparation, air bubbles were noticed in the hemostasis valve after the dilator was inserted into the delivery sheath.A decision was made to remove the dilator and device was flushed again with saline water through the flushing port and bypass hub with the hemostasis valve closed.During flushing, a continuous water drip leak was seen from the hemostasis valve knob.A decision was made to replace the delivery system with a 12f amplatzer amulet delivery sheath.The procedure continued with no report of adverse patient consequences.There was no clinically significant delay in the procedure due to this event.It was reported the original delivery system did not make patient contact.Patient status was reported as stable.
Additional Manufacturer Narrative
An event of water drip through the flushing port and bypass hub was reported.It was also reported that air bubbles were noticed in the hemostasis valve during device preparation.A kink was noted to be present in the sheath.The investigation confirmed the hemostasis valve met specifications when analyzed at abbott.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.One image and one video were received from field that appeared to demonstrate fluid leak from the hemostasis valve of steerable sheath.One image and one video were received from field that appeared to demonstrate fluid leak from the hemostasis valve of steerable sheath.The cause of the air ingress was unable to be conclusively determined, and a capa was initiated for further investigation on the root cause, per internal procedures.

• 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: 17114133
• Report Number: 2135147-2023-02545
• Device Sequence Number: 20691554
• Product Code: DQY
• UDI-Device Identifier: 05415067036025
• UDI-Public: 05415067036025
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: ASDS-14F-075
• Device Catalogue Number: ASDS-14F-075
• Device Lot Number: 8533920
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/24/2023
• Supplement Date Received by Manufacturer: 07/20/2023
• Initial Report FDA Received Date: 06/12/2023
• Supplement Report FDA Received Date: 07/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/22/2022
• 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
• Patient Sex: Unknown