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	12/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.
Event or Problem Description
It was reported that a balloon rupture occurred.Vascular access was obtained via the femoral artery.The 50% stenosed 200x 1.5to 4mm, eccentric, de novo target lesion was located in the mildly tortuous and mildly calcified doralis pedis artery.A 2.0mm x 80mm x 150cm sterling sl balloon catheter was advanced for dilation.However, when the device was placed in the lesion to performed the plasty, it was noted that there was blood flow in the insufflator and the balloon was broken.The device was removed and outside the patient's body, it was insufflated and was confirmed that it was broken.The procedure was completed with a different device.No patient complications were reported and the patient's status was stable.
Additional Manufacturer Narrative
Age at time of event: 18 years or older.Device evaluated by mfr.: returned product consisted of a sterling sl balloon catheter.The balloon was loosely folded, with fluid in the balloon and the inflation lumen.The tip, balloon, markerbands, inner/outer shaft (lumen) and hub were microscopically and visually inspected.Inspection revealed a perforation of the inner shaft that was located inside the hub.Functional testing was conducted by attaching an inflation device (filled with water), applying positive pressure.When pressure was applied, water was found to be leaking from the hub of the device.Investigation of the remainder of the device found no other damage or irregularities.
Event or Problem Description
It was reported that balloon rupture occurred.Vascular access was obtained via the femoral artery.The 50% stenosed 200x 1.5to 4mm, eccentric, de novo target lesion was located in the mildly tortuous and mildly calcified doralis pedis artery.A 2.0mm x 80mm x 150cm sterling sl balloon catheter was advanced for dilation.However, when the device was placed in the lesion to performed the plasty, it was noted that there was blood flow in the insufflator and the balloon was broken.The device was removed and outside the patient's body, it was insufflated and was confirmed that it was broken.The procedure was completed with a different device.No patient complications were reported and the patient's 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: 8190354
• Report Number: 2134265-2018-64600
• Device Sequence Number: 11290819
• Product Code: DQY
• UDI-Device Identifier: 08714729782247
• UDI-Public: 08714729782247
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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): 02/25/2019

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: 10/09/2020
• Device Model Number: 24702
• Device Catalogue Number: 24702
• Device Lot Number: 0022776213
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2019
• Initial Date Received by Manufacturer: 12/11/2018
• Supplement Date Received by Manufacturer: 02/02/2019
• Initial Report FDA Received Date: 12/21/2018
• Supplement Report FDA Received Date: 02/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1