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

Model Number	24690
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter city: (b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified iliac vein.A 8.0mm x 60mm x 135cm (4f) sterling balloon catheter was advanced for dilatation.However, during the initial inflation at 10 atmospheres for 10 seconds, the balloon was ruptured vertically in the middle part.The device was removed without any problem and the procedure was completed with a different device.There were no patient complications nor injuries reported and the patient condition was good.
Additional Manufacturer Narrative
E1- initial reporter city: (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 in the balloon 67mm from the tip.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed there is a pinhole in the balloon.
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified iliac vein.A 8.0mm x 60mm x 135cm (4f) sterling balloon catheter was advanced for dilatation.However, during the initial inflation at 10 atmospheres for 10 seconds, the balloon was ruptured vertically in the middle part.The device was removed without any problem and the procedure was completed with a different device.There were no patient complications nor injuries reported and the patient condition was good.

• 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: 14958564
• Report Number: 2124215-2022-24836
• Device Sequence Number: 5485883
• Product Code: DQY
• UDI-Device Identifier: 08714729757559
• UDI-Public: 08714729757559
• 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): 08/03/2022

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: 09/02/2023
• Device Model Number: 24690
• Device Catalogue Number: 24690
• Device Lot Number: 0025935578
• 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: 06/30/2022
• Supplement Date Received by Manufacturer: 07/29/2022
• Initial Report FDA Received Date: 07/08/2022
• Supplement Report FDA Received Date: 08/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2020
• 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