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	Non specific EKG/ECG Changes (1817)
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 an unknown date, an unknown device was chosen for implant with an amplatzer steerable delivery sheath.It was reported the patient exhibited minor st elevations due to air that resolved without intervention.No additional information was provided.
Event or Problem Description
This is being filed as a physician reported that there were about 6 patients who had st elevation that resolved within a few minutes and no interventions.It was suspected that the st elevation was due to air but was not confirmed as there was no confirmation of air visualized in the patient or the delivery system.  it was reported that on an unknown date, an unknown device was chosen for implant with an amplatzer steerable delivery sheath.It was reported the patient exhibited minor st elevations that resolved quickly without intervention.Air was able to be visualized on fluoroscopy imaging.It was noted that there were no major adverse patient effects.
Additional Manufacturer Narrative
An event of minor st elevations was reported.A returned device inspection to rule out any device-related causes could not be performed as the device was not returned for analysis.Information from the field indicated that the reported event resolved itself quickly.The field also indicated that the physician was able to visualize what looked like air on the fluoro images.No additional information was available for review.Based on the information received, the cause of the reported incident could not be conclusively determined.

• 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: 16463878
• Report Number: 2135147-2023-00943
• Device Sequence Number: 12390952
• Product Code: DQY
• UDI-Device Identifier: 05415067036025
• UDI-Public: 05415067036025
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 05/09/2023

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 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: 02/04/2023
• Supplement Date Received by Manufacturer: 05/04/2023
• Initial Report FDA Received Date: 03/01/2023
• Supplement Report FDA Received Date: 05/09/2023
• 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
• Patient Sex: Unknown