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

Model Number	24700
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/15/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that froze on wire occurred.The target lesion was located in the very heavily calcified left renal artery.A 6.0mmx60mmx135cm (4f) sterling balloon catheter was advanced for post-dilation.However, the balloon got stuck on the guidewire.The procedure was completed with another guidewire and balloon catheter.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of the sterling balloon catheter loaded onto the related guide wire.The balloon was tightly folded, and there was blood inside the wire lumen (inner shaft).There was 17.5 cm of guide wire sticking out of the tip and 92.9 cm sticking out from the hub of the device.The guide wire was measured at both ends, and each end measured.0175 inches.The tip, balloon, inner/outer shaft and hub were microscopically and visually inspected.Inspection revealed outer shaft damage (necked/ stretched) located 44.5 cm and 78 cm from the tip, and inner shaft damage (buckling) starting at the tack weld (11cm from tip) and the damage continued for 18 cm.Inspection of the remainder of the device revealed no other damage or irregularities.The guide wire could not be removed from the sterling catheter, so inner shaft (at tip and hub) could not be measured, and functional testing could not be performed.
Event or Problem Description
It was reported that froze on wire occurred.The target lesion was located in the very heavily calcified left renal artery.A 6.0mmx60mmx135cm (4f) sterling balloon catheter was advanced for post-dilation.However, the balloon got stuck on the guidewire.The procedure was completed with another guidewire and balloon catheter.No patient complications were reported.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8486812
• Report Number: 2134265-2019-03478
• Device Sequence Number: 2384072
• Product Code: DQY
• UDI-Device Identifier: 08714729123804
• UDI-Public: 08714729123804
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K053116
• 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): 05/06/2019

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: 03/04/2021
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0021816998
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2019
• Initial Date Received by Manufacturer: 03/15/2019
• Supplement Date Received by Manufacturer: 04/15/2019
• Initial Report FDA Received Date: 04/05/2019
• Supplement Report FDA Received Date: 05/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1