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

Model Number	24716
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that balloon deflation faillure occurred.The target lesion was located in the posterior tibial artery.A 2.5x220x150 sterling balloon catheter was advanced for post dilatation.However, after the balloon was inflated at 6 atmospheres, it would not deflate.The balloon was attempted to deflate by pulling negative pressure but was unsuccessful.The device was finally removed while it was still inflated by manual extraction.The procedure was completed with a non-boston scientific device.No patient complications were reported and the patient was doing well.
Event or Problem Description
It was reported that balloon deflation failure occurred.The target lesion was located in the posterior tibial artery.A 2.5x220x150 sterling balloon catheter was advanced for post dilatation.However, after the balloon was inflated at 6 atmospheres, it would not deflate.The balloon was attempted to deflate by pulling negative pressure but was unsuccessful.The device was finally removed while it was still inflated by manual extraction.The procedure was completed with a non-boston scientific device.No patient complications were reported and the patient was doing well.It was further reported that the balloon never deflated.A 50/50 saline-contrast ratio was used.A vascular surgeon removed the balloon intact over the course of four hours.
Additional Manufacturer Narrative
B5: describe event or problem: updated 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.Visual examination revealed that the inflation lumen is kinked 23.5cm from the tip.Microscopic examination revealed no additional damages.Inspection of the remainder of the device presented no other damage or irregularities.
Additional Manufacturer Narrative
B5 - describe event or problem: updated.
Event or Problem Description
It was reported that balloon deflation failure occurred.The target lesion was located in the posterior tibial artery.A 2.5x220x150 sterling balloon catheter was advanced for post dilatation.However, after the balloon was inflated at 6 atmospheres, it would not deflate.The balloon was attempted to deflate by pulling negative pressure but was unsuccessful.The device was finally removed while it was still inflated by manual extraction.The procedure was completed with a non-boston scientific device.No patient complications were reported and the patient was doing well.It was further reported that the balloon never deflated.A 50/50 saline-contrast ratio was used.A vascular surgeon removed the balloon intact over the course of four hours.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11813170
• Report Number: 2134265-2021-06010
• Device Sequence Number: 11575472
• Product Code: LIT
• UDI-Device Identifier: 08714729860075
• UDI-Public: 08714729860075
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K141112
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/25/2021

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: 07/19/2022
• Device Model Number: 24716
• Device Catalogue Number: 24716
• Device Lot Number: 0026662605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2021
• Initial Date Received by Manufacturer: 04/23/2021
• Supplement Date Received by Manufacturer: 05/12/2021; 06/04/2021
• Initial Report FDA Received Date: 05/12/2021
• Supplement Report FDA Received Date: 06/02/2021; 06/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention