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

Model Number	24703
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/17/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The moderately stenosed target lesion was located in the moderately tortuous and moderately calcified vein in the right lower extremity.A 4.0mm x 150mm x 150cm sterling balloon catheter was advanced for dilatation.However, during initial inflation at more or less than working pressure for a few seconds, the balloon ruptured.The device was removed and the procedure was completed with another of the same device.There were no patient complications reported and the patient status was stable.
Additional Manufacturer Narrative
D4: lot number corrected from 0025529202 to 0025515757.Expiration date corrected from 05/21/2022 to 05/15/2022.H4: device manufacture date corrected from 05/21/2020 to 05/15/2020.
Event or Problem Description
It was reported that balloon rupture occurred.The moderately stenosed target lesion was located in the moderately tortuous and moderately calcified vein in the right lower extremity.A 4.0mm x 150mm x 150cm sterling balloon catheter was advanced for dilatation.However, during initial inflation at more or less than working pressure for a few seconds, the balloon ruptured.The device was removed and the procedure was completed with another of the same device.There were no patient complications reported and the patient status was stable.
Additional Manufacturer Narrative
Device evaluated 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 and blood in the inflation lumen and balloon.The balloon was loosely folded.Microscopic inspection revealed tip damage.The device was prepped with an inflation device filled with water and connected to the inflation port to inflate the device.There was a pinhole 59mm from the distal marker band.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that balloon rupture occurred.The moderately stenosed target lesion was located in the moderately tortuous and moderately calcified vein in the right lower extremity.A 4.0mm x 150mm x 150cm sterling balloon catheter was advanced for dilatation.However, during initial inflation at more or less than working pressure for a few seconds, the balloon ruptured.The device was removed and the procedure was completed with another of the same device.There were no patient complications 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: 10945670
• Report Number: 2134265-2020-16936
• Device Sequence Number: 3056623
• Product Code: DQY
• UDI-Device Identifier: 08714729782384
• UDI-Public: 08714729782384
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Followup
• Report Date (Section B): 01/07/2021

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: 05/15/2022
• Device Model Number: 24703
• Device Catalogue Number: 24703
• Device Lot Number: 0025515757
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2020
• Initial Date Received by Manufacturer: 11/18/2020
• Supplement Date Received by Manufacturer: 12/16/2020; 01/05/2021
• Initial Report FDA Received Date: 12/04/2020
• Supplement Report FDA Received Date: 12/21/2020; 01/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 65