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	05/08/2020
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 a moderately tortuous shunt vessel.A 4.0mmx20mmx80cm (4f) sterling balloon catheter was advanced for dilatation.However, during first inflation at 6 atmospheres, the balloon ruptured.The device was remove and the procedure was completed with another of the same device.There were no patient complications reported.
Additional Manufacturer Narrative
E1: initial reporter address: (b)(6).E1: initial reporter city: (b)(6).Device evaluated by mfr.: the shaft, hypotube, tip and balloon were microscopically and visually examined.There was contrast and blood in the inflation lumen and balloon, and blood in the guidewire lumen.The balloon was loosely folded.The device was prepped with an inflation device filled with water and connected to the inflation port to inflate the device.There was a pinhole 3mm proximal of the distal marker band.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed the reported balloon ruptured.
Event or Problem Description
It was reported that balloon rupture occurred.The 99% stenosed target lesion was located in a moderately tortuous coronary artery.A 4.0mmx20mmx80cm (4f) sterling balloon catheter was advanced for dilation.However, during first inflation at 6 atmospheres, the balloon ruptured.The procedure was completed with another of same device.There were no patient complications 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: 10059788
• Report Number: 2134265-2020-06559
• Device Sequence Number: 3358441
• Product Code: DQY
• UDI-Device Identifier: 08714729123545
• UDI-Public: 08714729123545
• 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): 07/14/2020

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: 04/25/2022
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0023699280
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2020
• Initial Date Received by Manufacturer: 05/11/2020
• Supplement Date Received by Manufacturer: 07/09/2020
• Initial Report FDA Received Date: 05/14/2020
• Supplement Report FDA Received Date: 07/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1