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

Model Number	24690
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that deflation issue occurred.The 100% stenosed target lesion was located in the moderately tortuous and severely calcified superficial femoral artery.A 6.0mmx150mmx150cm sterling balloon catheter was for dilatation.The balloon was initially inflated at 6 atmospheres for 30 seconds with an iohexol dilution ratio of 1:1.However, deflation trouble has occurred.Eventually, the balloon was deflated with a deflation time of 10 minutes and was removed intact from the patient.The procedure was completed with another of same device.There were no patient complications reported.
Additional Manufacturer Narrative
Returned product consisted of a sterling balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed that the inflation lumen is stretched 122mm from the hub.Microscopic examination revealed no additional damages.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis found damage to the device that would have contributed to the reported event.
Event or Problem Description
It was reported that deflation issue occurred.The 100% stenosed target lesion was located in the moderately tortuous and severely calcified superficial femoral artery.A 6.0mmx150mmx150cm sterling balloon catheter was for dilatation.The balloon was initially inflated at 6 atmospheres for 30 seconds with an iohexol dilution ratio of 1:1.However, deflation trouble has occurred.Eventually, the balloon was deflated with a deflation time of 10 minutes and was removed intact from the patient.The procedure was completed with another of same device.There were no patient complications 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16386201
• Report Number: 2124215-2023-05302
• Device Sequence Number: 5592636
• Product Code: LIT
• UDI-Device Identifier: 08714729859611
• UDI-Public: 08714729859611
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K141150
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2023

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: 10/26/2025
• Device Model Number: 24690
• Device Catalogue Number: 24690
• Device Lot Number: 0030430460
• 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: 01/27/2023
• Supplement Date Received by Manufacturer: 02/16/2023
• Initial Report FDA Received Date: 02/16/2023
• Supplement Report FDA Received Date: 02/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2022
• 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