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	07/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in a vessel in a lower limb.A 2.5mm x 150mm x 150cm sterling sl balloon catheter was advanced for dilatation.However, during inflation, the balloon ruptured.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in a vessel in a lower limb.A 2.5mm x 150mm x 150cm sterling sl balloon catheter was advanced for dilatation.However, during inflation, the balloon ruptured.The procedure was completed with another of the same device.No patient complications were reported and the patient status was stable.Returned product consisted of a sterling sl balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed two buckling sections on the inner lumen in the balloon.They are located at 14.5cm and another at 15cm from the tip.The microscopic examination revealed the tip is damaged and there is a pinhole in the inner lumen located at the 15cm buckling section.Blood is visible in the inflation lumen and balloon.Inspection of the remainder of the device presented no other damage or irregularities.

• 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: 7798036
• Report Number: 2134265-2018-60291
• Device Sequence Number: 19118444
• Product Code: DQY
• UDI-Device Identifier: 08714729782278
• UDI-Public: 08714729782278
• 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
• Report Date (Section B): 10/08/2018

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: 01/31/2020
• Device Model Number: 24703
• Device Catalogue Number: 24703
• Device Lot Number: 0021685685
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2018
• Initial Date Received by Manufacturer: 07/30/2018
• Supplement Date Received by Manufacturer: 09/13/2018
• Initial Report FDA Received Date: 08/20/2018
• Supplement Report FDA Received Date: 10/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1