MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION STERLING; CATHETER, PERCUTANEOUS

Model Number	24716
Medical Device Problem Codes	Inflation Problem (1310); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/28/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 03-oct-2018.It was reported that balloon deformation and slow inflation occurred.The target lesion was located in the superficial femoral artery.A 4.0x220x150 (4f) sterling balloon catheter was advanced for dilatation.However, during inflation there was a tiny portion of the balloon that did not inflate.It looks like there was a ring around the balloon that would not let it inflate.The device was removed from the patients body.The device was inflated once again to see the defect.The procedure with this device.No patient complications were reported and the patient status was fine.However, device analysis revealed a pinhole device evaluated by manufacturer: the returned analysis revealed the tip, balloon, markerbands, and inner/outer shaft were microscopically and visually inspected.Inspection revealed witness marks in the balloon material located 8.2 cm from the tip, with balloon damage (pinch in material) located 7 cm and 21 cm from the tip, tip damage, and a pinhole in the balloon material located 12 mm distal from the proximal markerband.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8000638
• Report Number: 2134265-2018-62253
• Device Sequence Number: 11109162
• Product Code: LIT
• UDI-Device Identifier: 08714729860310
• UDI-Public: 08714729860310
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K141112
• 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
• Report Date (Section B): 10/24/2018

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: 09/19/2019
• Device Model Number: 24716
• Device Catalogue Number: 24716
• Device Lot Number: 0021901705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2018
• Initial Report FDA Received Date: 10/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1