MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION STERLING; CATHETER, PERCUTANEOUS

Model Number	24700
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that deflation failure occurred.The patient presented with peripheral artery disease and underwent angiogram.A 8.0mmx40mmx135cm (4f) sterling balloon catheter was advanced for dilatation.The balloon was attempted to be deflated for 20 mins during removal but would not deflate.The balloon was poked with wires and was eventually popped by puncturing it with a needle through the common femoral artery.The procedure was completed with another of same device and no patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: the complaint device was not received at the complaint investigation site for analysis.However, media was provided in the form of a video and two photos.The first photo shows the hub portion of the device.It is very bloody and the guidewire lumen cannot be seen inside the inflation lumen.The second photo shows the distal section of the balloon and parts of the shaft.There is visible blood inside the balloon and the guidewire lumen is still inside the device.The video shows someone using a syringe and pushing fluid into the inflation lumen.The fluid can be seen coming out of the inflation port.As the video pans out majority of the device can be seen.The guidewire lumen is not no longer connected to the hub and appears to have moved distally inside the inflation lumen.
Event or Problem Description
It was reported that deflation failure occurred.The patient presented with peripheral artery disease and underwent angiogram.A 8.0mmx40mmx135cm (4f) sterling balloon catheter was advanced for dilatation.The balloon was attempted to be deflated for 20 mins during removal but would not deflate.The balloon was poked with wires and was eventually popped by puncturing it with a needle through the common femoral artery.The procedure was completed with another of same device and no patient complications were reported.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16611119
• Report Number: 2124215-2023-11781
• Device Sequence Number: 11994776
• Product Code: DQY
• UDI-Device Identifier: 08714729720676
• UDI-Public: 08714729720676
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K053116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2023

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: 10/20/2025
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0030395478
• 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: 03/03/2023
• Supplement Date Received by Manufacturer: 03/31/2023
• Initial Report FDA Received Date: 03/24/2023
• Supplement Report FDA Received Date: 04/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2022
• 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: Required Intervention
• Patient Sex: Unknown