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	02/13/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in a shunt in the moderately tortuous and severely calcified limb.A 6.0mmx100mmx80cm sterling balloon catheter was advanced for dilation.However, during inflation, the balloon ruptured.The device was removed from the patient and the procedure was completed with another of the same device.There were no patient complications nor injuries reported.
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in a shunt in the moderately tortuous and severely calcified limb.A 6.0mmx100mmx80cm sterling balloon catheter was advanced for dilation.However, during inflation, the balloon ruptured.The device was removed from the patient and the procedure was completed with another of the same device.There were no patient complications nor injuries reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a sterling otw balloon catheter.The balloon was loosely folded, with fluid in the balloon and shaft.Analysis of the tip, balloon, markerbands, and inner/outer shaft included microscopic and visual inspection.Inspection revealed a pinhole in the balloon material located 66mm proximal of the distal markerband.Inspection of the rest of the device found no other damage or defect.The reported ruptured balloon was confirmed.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9772247
• Report Number: 2134265-2020-02319
• Device Sequence Number: 2704315
• Product Code: DQY
• UDI-Device Identifier: 08714729123699
• UDI-Public: 08714729123699
• 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): 04/01/2020

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: 09/11/2022
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0024417654
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2020
• Initial Date Received by Manufacturer: 02/13/2020
• Supplement Date Received by Manufacturer: 03/20/2020
• Initial Report FDA Received Date: 02/28/2020
• Supplement Report FDA Received Date: 04/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1