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

Model Number	24702
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/03/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon ruptured occurred.The target lesion was located in a vessel below the knee.A 3.0mm x 100mm x 150cm sterling balloon catheter was advanced for dilatation.However, upon initial inflation at 4 atmospheres, the balloon was ruptured.The procedure was completed with another of the same device.There were no patient complications nor injuries were reported.
Additional Manufacturer Narrative
Device evalauted by mfr.: returned product consisted of a sterling sl balloon catheter.The balloon was loosely folded and there was blood in the inflation lumen.The tip, balloon, markerbands and inner/outer shaft of the returned device were microscopically and visually inspected.Inspection revealed a pinhole in the balloon material that was 5cm from the tip of the device.Inspection of the rest of the device found no other damage or defect.
Event or Problem Description
It was reported that balloon ruptured occurred.The target lesion was located in a vessel below the knee.A 3.0mm x 100mm x 150cm sterling balloon catheter was advanced for dilatation.However, upon initial inflation at 4 atmospheres, the balloon was ruptured.The procedure was completed with another of the same device.There were no patient complications nor injuries were reported.

• 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: 8814494
• Report Number: 2134265-2019-08587
• Device Sequence Number: 19479751
• Product Code: DQY
• UDI-Device Identifier: 08714729782292
• UDI-Public: 08714729782292
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K093720
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2019

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: 04/23/2021
• Device Model Number: 24702
• Device Catalogue Number: 24702
• Device Lot Number: 0023685398
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2019
• Initial Date Received by Manufacturer: 07/03/2019
• Supplement Date Received by Manufacturer: 08/06/2019
• Initial Report FDA Received Date: 07/22/2019
• Supplement Report FDA Received Date: 08/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR