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

Model Number	24702
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/04/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon pinhole occurred.The target lesion was located in the left anterior tibial artery.After atherectomy was performed, a 3.0mm x 100mm x 150cm sterling sl balloon catheter was advanced for dilation.However, the balloon would not hold the atmosphere pressure.During removal and as they withdraw back to collapse the balloon, blood started coming.When the device was removed, the balloon was filled up and a pinhole at the distal tip was noted.The procedure was completed with a non-bsc device.No patient complications were reported.
Event or Problem Description
It was reported that balloon pinhole occurred.The target lesion was located in the left anterior tibial artery.After atherectomy was performed, a 3.0mm x 100mm x 150cm sterling sl balloon catheter was advanced for dilation.However, the balloon would not hold the atmosphere pressure.During removal and as they withdraw back to collapse the balloon, blood started coming.When the device was removed, the balloon was filled up and a pinhole at the distal tip was noted.The procedure was completed with a non-bsc device.No patient complications were reported.Device evaluated by mfr: returned device consisted of a sterling otw balloon catheter.The balloon was loosely folded with blood in the balloon and inner lumen.The tip, balloon, markerbands, and inner/outer shaft were microscopically and visually inspected.Inspection revealed tip damage, and two pinholes in the balloon material that were located at the edges of the distal markerband.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The device was functionally tested by attaching an inflation device (filled with water) to the hub of the sterling device.When positive pressure was applied to the device, water was found to be streaming out from the pinholes in the balloon material, and the device could not be brought to rated burst pressure and could not hold pressure.

• 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: 7996950
• Report Number: 2134265-2018-62057
• Device Sequence Number: 1669794
• 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): 11/19/2018

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: 04/01/2020
• Device Model Number: 24702
• Device Catalogue Number: 24702
• Device Lot Number: 0021935533
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2018
• Initial Date Received by Manufacturer: 10/04/2018
• Supplement Date Received by Manufacturer: 10/29/2018
• Initial Report FDA Received Date: 10/23/2018
• Supplement Report FDA Received Date: 11/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR