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	08/16/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the mildly tortuous and heavily calcified left superficial femoral artery.A 5.0 x150, 135cm charger balloon catheter was advanced for dilatation.However, during inflation to a nominal pressure, the balloon ruptured.The device was completely removed from the patient's body.A 5.0mmx80mmx135cm (4f) sterling balloon catheter was then advanced for dilatation.However, upon inflation to a nominal pressure, the balloon also ruptured.The device was completely removed from the patient's body and the procedure was completed with a different device.No patient complications were reported and the patient's status was fine.
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the mildly tortuous and heavily calcified left superficial femoral artery.A 5.0 x150, 135cm charger balloon catheter was advanced for dilatation.However, during inflation to a nominal pressure, the balloon ruptured.The device was completely removed from the patient's body.A 5.0mmx80mmx135cm (4f) sterling balloon catheter was then advanced for dilatation.However, upon inflation to a nominal pressure, the balloon also ruptured.The device was completely removed from the patient's body and the procedure was completed with a different device.No patient complications were reported and the patient's status was fine.Returned product consisted of a sterling balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Microscopic examination revealed the tip is damaged and there is a pinhole in the balloon located at the 14mm from the tip.Blood is present inside the balloon.Inspection of the remainder of the device presented no other damage or irregularities.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 7860170
• Report Number: 2134265-2018-60885
• Device Sequence Number: 11120648
• Product Code: DQY
• UDI-Device Identifier: 08714729122951
• UDI-Public: 08714729122951
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K053116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2018

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: 07/01/2021
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0022327464
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2018
• Initial Date Received by Manufacturer: 08/17/2018
• Supplement Date Received by Manufacturer: 09/13/2018
• Initial Report FDA Received Date: 09/10/2018
• Supplement Report FDA Received Date: 10/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR