MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION STERLING SL; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	24703
Medical Device Problem Codes	Break (1069); Inflation Problem (1310)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/30/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The 50% stenosed target lesion was located in the mildly tortuous and moderately calcified anterior tibial artery.A 2.5mm x 120mm x 150cm sterling sl balloon catheter was advanced for dilatation.The device was inflated thrice at 10 atmospheres; however, during inflation, contrast could not be seen.It was initially suspected that the contrast was too diluted; however, when the balloon was removed and inflated outside, it was found that it could not inflate.No visible pinhole noted with the device.As per physician, the balloon shaft was faulty or broken.The procedure was completed with another of same device.No patient complications were reported and the patient's status was stable.
Additional Manufacturer Narrative
Device evaluation by mfr: returned product consisted of a sterling sl balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There was contrast in the inflation lumen and balloon, and blood in the guidewire lumen.The balloon was loosely folded.The outer shaft was stretched down 36mm from the strain relief for 23mm.The device was prepped with an inflation device filled with water and connected to the inflation port to inflate the device.The device was slow to inflate and was unable to deflate.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed there would have been difficulty inflating the balloon.
Event or Problem Description
It was reported that shaft break occurred.The 50% stenosed target lesion was located in the mildly tortuous and moderately calcified anterior tibial artery.A 2.5mm x 120mm x 150cm sterling sl balloon catheter was advanced for dilatation.The device was inflated thrice at 10 atmospheres; however, during inflation, contrast could not be seen.It was initially suspected that the contrast was too diluted; however, when the balloon was removed and inflated outside, it was found that it could not inflate.No visible pinhole noted with the device.The physician believed that the balloon shaft was faulty or broken.The procedure was completed with another of same device.No patient complications were reported and the patient status was stable.

• Brand Name: STERLING SL
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11004056
• Report Number: 2134265-2020-17538
• Device Sequence Number: 869461
• Product Code: DQY
• UDI-Device Identifier: 08714729782261
• UDI-Public: 08714729782261
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K093720
• 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): 01/14/2021

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: 06/30/2022
• Device Model Number: 24703
• Device Catalogue Number: 24703
• Device Lot Number: 0025654341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2020
• Initial Date Received by Manufacturer: 12/03/2020
• Supplement Date Received by Manufacturer: 01/14/2021
• Initial Report FDA Received Date: 12/14/2020
• Supplement Report FDA Received Date: 01/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1