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	05/31/2019
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 severely calcified superior vena cava.A 9.0 mm x 20 mm x 135 cm (5f) sterling balloon catheter was advanced for dilatation.However, during the first inflation at 5 atmospheres for 5 seconds, the balloon ruptured.The procedure was completed with another of the same device.No patient complications were 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 inflation lumen.The tip, markerband, balloon, proximal weld, and inner/outer shaft were microscopically and visually inspected.Inspection revealed a burst in the balloon material that was 10mm in length.The rest of the device was inspected, and no other damage or irregularities were found.
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the mildly tortuous and severely calcified superior vena cava.A 9.0mmx20mmx135cm (5f) sterling balloon catheter was advanced for dilatation.However, during the first inflation at 5 atmospheres for 5 seconds, the balloon ruptured.The procedure was completed with another of the same device.No patient complications 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: 8680977
• Report Number: 2134265-2019-06595
• Device Sequence Number: 16609341
• Product Code: DQY
• UDI-Device Identifier: 08714729720744
• UDI-Public: 08714729720744
• 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): 07/10/2019

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: 03/31/2020
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0020462689
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2019
• Initial Date Received by Manufacturer: 05/31/2019
• Supplement Date Received by Manufacturer: 06/28/2019
• Initial Report FDA Received Date: 06/07/2019
• Supplement Report FDA Received Date: 07/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1