MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION STERLING; CATHETER, PERCUTANEOUS

Model Number	24716
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/14/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloon ruptured.A 5.0x200x90 sterling balloon catheter and a 5.0x220x90 sterling balloon catheter were selected for a percutaneous transluminal angioplasty of the heavily calcified superficial femoral artery.During the procedure inside the patient, both balloons ruptured.The 5.0x200x90 sterling balloon ruptured at 12atm and the 5.0x220x90 sterling balloon ruptured at 13atm.The procedure was completed with another sterling balloon catheter.There were no patient complications reported.
Additional Manufacturer Narrative
Device eval by manufacturer: returned product consisted of a sterling balloon catheter.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.There was a pinhole 43mm distal from the marker band.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that the balloon ruptured.A 5.0x200x90 sterling balloon catheter and a 5.0x220x90 sterling balloon catheter were selected for a percutaneous transluminal angioplasty of the heavily calcified superficial femoral artery.During the procedure inside the patient, both balloons ruptured.The 5.0x200x90 sterling balloon ruptured at 12atm and the 5.0x220x90 sterling balloon ruptured at 13atm.The procedure was completed with another sterling balloon catheter.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: 8906435
• Report Number: 2134265-2019-09911
• Device Sequence Number: 16823392
• Product Code: LIT
• UDI-Device Identifier: 08714729845416
• UDI-Public: 08714729845416
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K132430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2019

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: 06/30/2020
• Device Model Number: 24716
• Device Catalogue Number: 24716
• Device Lot Number: 0023130411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2019
• Initial Date Received by Manufacturer: 08/14/2019
• Supplement Date Received by Manufacturer: 10/03/2019
• Initial Report FDA Received Date: 08/19/2019
• Supplement Report FDA Received Date: 10/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1