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	05/14/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in a shunt in the mildly tortuous and moderately calcified cephalic vein.After a 4fr non-bsc introducer sheath was placed and a 0.018 inch non-bsc guidewire crossed the lesion, a 4.0mmx20mmx40cm (4f) sterling balloon catheter was advanced for dilatation.However, during the second inflation at 6 atmospheres for 10 seconds, the balloon ruptured.The device was replaced with a 4mmx4cm mustang balloon catheter which was inflated at 15 atmospheres.The lesion was sufficiently dilated and the procedure was completed.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: 8647516
• Report Number: 2134265-2019-05957
• Device Sequence Number: 2386879
• Product Code: DQY
• UDI-Device Identifier: 08714729123538
• UDI-Public: 08714729123538
• 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
• Report Date (Section B): 05/28/2019

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: 11/08/2021
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0022917379
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2019
• Initial Report FDA Received Date: 05/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 0.018INCH RADIFOCUS; 4FR MEDIKIT SHEATH; EVEREST