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

Model Number	24700
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The 99% stenosed target lesion was located in the mildly tortuous and severely calcified superficial femoral artery.A 5.0mmx100mmx80cm sterling balloon catheter was advanced for dilatation.However, during initial inflation at 3 atmospheres, the balloon ruptured.The device was removed and the procedure was completed with a different device.No patient complications nor injuries were reported.
Additional Manufacturer Narrative
(b)(6).Device evaluated by mfr.:returned product consisted of a sterling balloon catheter.Microscopic examination revealed that there was a hole inner shaft within the hub.A test inflation device was connected to the hub and pressurized inflating the device to rated burst pressure 14atm.The device leaked at the hub.The reported balloon burst was not confirmed; however, the hole in the inner shaft caused the balloon not to inflate.
Event or Problem Description
It was reported that balloon rupture occurred.The 99% stenosed target lesion was located in the mildly tortuous and severely calcified superficial femoral artery.A 5.0mmx100mmx80cm sterling balloon catheter was advanced for dilatation.However, during initial inflation at 3 atmospheres, the balloon ruptured.The device was removed and the procedure was completed with a different device.No patient complications nor injuries were 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: 9428193
• Report Number: 2134265-2019-15104
• Device Sequence Number: 2093760
• Product Code: DQY
• UDI-Device Identifier: 08714729122821
• UDI-Public: 08714729122821
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K053116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2020

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: 06/27/2021
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0022313388
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2019
• Initial Date Received by Manufacturer: 11/27/2019
• Supplement Date Received by Manufacturer: 01/09/2020
• Initial Report FDA Received Date: 12/06/2019
• Supplement Report FDA Received Date: 01/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1