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	04/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.(b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The 75% stenosed target lesion was located in the moderately tortuous and severely calcified common iliac artery.A 8.0mmx20mmx135cm (4f) sterling balloon catheter was advanced for dilatation.The device was inflated to nominal pressure for 3 minutes on the first inflation, and then inflated to nominal pressure for 1 minute on the second inflation.However, during the third inflation at 17 atmospheres for 30 seconds, the balloon ruptured.The procedure was completed with a different device.There were no patient complications nor injuries reported.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11773270
• Report Number: 2134265-2021-05677
• Device Sequence Number: 3438741
• Product Code: DQY
• UDI-Device Identifier: 08714729757498
• UDI-Public: 08714729757498
• 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: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/04/2021

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: 11/07/2021
• Device Model Number: 24690
• Device Catalogue Number: 24690
• Device Lot Number: 0022909781
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/20/2021
• Initial Report FDA Received Date: 05/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1