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	03/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that deflation failure occurred requiring additional intervention.The patient presented with peripheral vascular disease and underwent angioplasty in an occluded artery.The target lesion was located in the superficial femoral artery.A 6.0mmx60mmx135cm (4f) sterling balloon catheter was advanced for dilatation.The balloon was inflated using the standard procedure; however, the balloon would not deflate when negative pressure was applied multiple attempts.The whole system had to be withdrawn as the balloon could not be removed through the sheath leaving a much larger hole in the patient's artery.Additional interventions were required to close the artery prolonging the procedure.The procedure was completed using an alternate method.
Additional Manufacturer Narrative
Returned product consisted of a sterling balloon catheter with an unknown sheath.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed that the inflation lumen is stretched and buckled 48.8cm from the tip.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 could have contributed to the reported event.
Event or Problem Description
It was reported that deflation failure occurred requiring additional intervention.The patient presented with peripheral vascular disease and underwent angioplasty in an occluded artery.The target lesion was located in the superficial femoral artery.A 6.0mmx60mmx135cm (4f) sterling balloon catheter was advanced for dilatation.The balloon was inflated using the standard procedure; however, the balloon would not deflate when negative pressure was applied multiple attempts.The whole system had to be withdrawn as the balloon could not be removed through the sheath leaving a much larger hole in the patient's artery.Additional interventions were required to close the artery prolonging the procedure.The procedure was completed using an alternate method.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• 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: 16635359
• Report Number: 2124215-2023-12553
• Device Sequence Number: 6117626
• Product Code: DQY
• UDI-Device Identifier: 08714729123804
• UDI-Public: 08714729123804
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2023

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: 09/22/2025
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0030204966
• 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: 03/08/2023
• Supplement Date Received by Manufacturer: 04/27/2023
• Initial Report FDA Received Date: 03/29/2023
• Supplement Report FDA Received Date: 05/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2022
• 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