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	09/09/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.Vascular access was obtained via the antegrade approach from the forearm.The 75% stenosed target lesion was located in the mildly tortuous and non-calcified vein in the left elbow.After a non-bsc guide wire was crossed the lesion, a 5.0mmx100mmx80cm (4f) sterling balloon catheter was advanced for dilatation.However, during first inflation at 6 atmospheres for 30 seconds, the balloon ruptured.The procedure was completed with different device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: 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.Microscopic inspection revealed tip damage.The device was soaked in a water bath for 15 days to loosen the blood and contrast in the device.The device was prepped with an inflation device filled with water and connected to the inflation port to inflate the device.There was a hole in the inner shaft 45mm proximal from the distal marker band.The device was functionally tested with a.018" guidewire.The hole in the inner shaft is consistent with an interaction with a guidewire.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that balloon rupture occurred.Vascular access was obtained via the antegrade approach from the forearm.The 75% stenosed target lesion was located in the mildly tortuous and non-calcified vein in the left elbow.After a non-bsc guide wire was crossed the lesion, a 5.0mmx100mmx80cm (4f) sterling balloon catheter was advanced for dilatation.However, during first inflation at 6 atmospheres for 30 seconds, the balloon ruptured.The procedure was completed with different 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: 9151200
• Report Number: 2134265-2019-11892
• Device Sequence Number: 3123314
• Product Code: DQY
• UDI-Device Identifier: 08714729122821
• UDI-Public: 08714729122821
• 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): 12/09/2019

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: 07/18/2022
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0024133522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2019
• Initial Date Received by Manufacturer: 09/11/2019
• Supplement Date Received by Manufacturer: 12/04/2019
• Initial Report FDA Received Date: 10/03/2019
• Supplement Report FDA Received Date: 12/09/2019
• 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: GUIDE WIRE: BUDDY/018; GUIDE WIRE: BUDDY/018; INTRODUCER SHEATH: RADIFOCUS/5FR; INTRODUCER SHEATH: RADIFOCUS/5FR