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	08/20/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in an arterial occlusion in the lower limb.A 2.5mm x 100mm x 150cm sterling sl balloon catheter was advanced for dilatation.However, upon inflation within specified pressure, the balloon ruptured.The device was completely removed from the patient and the procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in an arterial occlusion in the lower limb.A 2.5mm x 100mm x 150cm sterling sl balloon catheter was advanced for dilatation.However, upon inflation within specified pressure, the balloon ruptured.The device was completely removed from the patient and the procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.Returned product consisted of a sterling sl balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There was blood in the inflation lumen.The balloon was tightly folded.Microscopic examination revealed that there was no damage to the balloon; however, there was a hole in the inner shaft 13.5cm proximal of the tip.There was damage distal of the shaft hole.The distal tip was damaged.Inspection 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: 7883176
• Report Number: 2134265-2018-61065
• Device Sequence Number: 11444526
• Product Code: DQY
• UDI-Device Identifier: 08714729782254
• UDI-Public: 08714729782254
• 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): 10/12/2018

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: 03/31/2019
• Device Model Number: 24702
• Device Catalogue Number: 24702
• Device Lot Number: 0020435824
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2018
• Initial Date Received by Manufacturer: 08/23/2018
• Supplement Date Received by Manufacturer: 09/20/2018
• Initial Report FDA Received Date: 09/17/2018
• Supplement Report FDA Received Date: 10/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1