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	06/27/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.Vascular access was obtained by ipsilateral retrograde approach.The 99% stenosed target lesion was located in the moderately tortuous and moderately calcified external iliac artery.After a 6fr non-bsc guiding sheath was placed and a guidewire crossed the lesion, pre-dilatation was performed by a non-bsc balloon catheter.An epic stent was placed, then a 9.0mmx20mmx80cm (5f) sterling balloon catheter was advanced for post-dilatation.However, on the second or third inflation at below rated burst pressure, the balloon ruptured.The procedure was completed with a different 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: 8810033
• Report Number: 2134265-2019-08540
• Device Sequence Number: 19634650
• Product Code: DQY
• UDI-Device Identifier: 08714729720751
• UDI-Public: 08714729720751
• 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): 07/21/2019

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: 12/07/2021
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0023052649
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2019
• Initial Report FDA Received Date: 07/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1