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

Model Number	24700
Medical Device Problem Codes	Deflation Problem (1149); Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that deflation failure occurred.The target lesion was located in left cephalic vein.A 5.0mmx40mmx135cm sterling balloon catheter was advanced for dilation.The balloon was held to 10 atmospheres, however, it would not inflate.When it was removed from the body, it was noted to be fully deflated and when attempted to inflate outside the body, it did finally inflate, but it would not deflate at all.The procedure was completed with a 5x40 non-boston scientific device.There were no patient complications nor injuries reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a sterling balloon catheter.The outer shaft, inner shaft, balloon, and tip were visually and microscopically examined.The catheter batch number is a match to the complaint batch number.Visual examination showed a kink 95 cm from the hub.Microscopic examination revealed a kink at the marker band under the balloon.The device was inflated but it took about a minute to fully inflate.When deflating the device it took approximate 1 minute.The account may not have been in a position to wait for the device to deflate.Device analysis determined the condition of the returned device was not consistent with the reported information of failure to inflate and failure to deflate.
Event or Problem Description
It was reported that deflation failure occurred.The target lesion was located in left cephalic vein.A 5.0mmx40mmx135cm sterling balloon catheter was advanced for dilation.The balloon was held to 10 atmospheres, however, it would not inflate.When it was removed from the body, it was noted to be fully deflated and when attempted to inflate outside the body, it did finally inflate, but it would not deflate at all.The procedure was completed with a 5x40 non-boston scientific device.There were no patient complications nor injuries 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: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14187128
• Report Number: 2134265-2022-04072
• Device Sequence Number: 12245406
• Product Code: DQY
• UDI-Device Identifier: 08714729122906
• UDI-Public: 08714729122906
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 05/24/2022

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: 02/25/2024
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0026870913
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/31/2022
• Supplement Date Received by Manufacturer: 05/05/2022
• Initial Report FDA Received Date: 04/22/2022
• Supplement Report FDA Received Date: 05/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2021
• 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 Age: 54 YR
• Patient Sex: Male
• Patient Race: White