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

Model Number	24690
Medical Device Problem Codes	Leak/Splash (1354); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter address: (b)(6).
Event or Problem Description
It was reported that balloon rupture occured.The 75% stenosed target lesion was located in the non calcified common carotid artery.A 4.0mm x 20mm x 135cm sterling balloon catheter was advanced for dilatation.However, angiography showed leakage of contrast medium during inflation.The balloon was removed from the patient and the procedure was completed with another of the same device.There were no patient complications reported and the patient condition was fine.
Additional Manufacturer Narrative
E1.Initial reporter address: (b)(6).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 no damages.Microscopic examination revealed a pinhole 20mm from the tip.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that balloon rupture occured.The 75% stenosed target lesion was located in the non calcified common carotid artery.A 4.0mm x 20mm x 135cm sterling balloon catheter was advanced for dilatation.However, angiography showed leakage of contrast medium during inflation.The balloon was removed from the patient and the procedure was completed with another of the same device.There were no patient complications reported and the patient condition was fine.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12446995
• Report Number: 2134265-2021-11283
• Device Sequence Number: 11608726
• Product Code: DQY
• UDI-Device Identifier: 08714729756958
• UDI-Public: 08714729756958
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2021

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: 10/27/2022
• Device Model Number: 24690
• Device Catalogue Number: 24690
• Device Lot Number: 0024667256
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2021
• Initial Date Received by Manufacturer: 08/20/2021
• Supplement Date Received by Manufacturer: 09/23/2021
• Initial Report FDA Received Date: 09/09/2021
• Supplement Report FDA Received Date: 10/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR