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

Model Number	24716
Medical Device Problem Codes	Deflation Problem (1149); Inflation Problem (1310)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/17/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon deflation failure occurred.The target lesion was located in the left superficial femoral artery.A 4.0x220x150 sterling balloon catheter was advanced for dilatation.However, difficulties were encountered upon inflating the balloon.High pressure was used and once inflated, the balloon would not deflate.The procedure was completed with another of the same device.There were no patient complications reported.
Event or Problem Description
It was reported that balloon deflation failure occurred.The target lesion was located in the left superficial femoral artery.A 4.0x220x150 sterling balloon catheter was advanced for dilatation.However, difficulties were encountered upon inflating the balloon.High pressure was used and once inflated, the balloon would not deflate.The procedure was completed with another of the same device.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a sterling otw balloon catheter.The device was bloody, and the balloon was partially filled with fluid.Analysis of the tip, balloon, and inner/outer shaft included microscopic and visual inspection.Inspection revealed the balloon had inverted over the tip of the balloon, the inner shaft was separated 123cm form the strain relief, the outer shaft was damaged (necked) for 36cm that started 1.5.5cm from the strain relief.Inspection of the rest of the device found no other damage or defect.The hub of the catheter was attached to an inflation device (filled with water).Positive pressure was applied, but the balloon could not inflate, and when negative pressure was applied, the fluid in the balloon could not be deflated.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9903498
• Report Number: 2134265-2020-04137
• Device Sequence Number: 754910
• Product Code: LIT
• UDI-Device Identifier: 08714729860310
• UDI-Public: 08714729860310
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 05/01/2020

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: 07/15/2021
• Device Model Number: 24716
• Device Catalogue Number: 24716
• Device Lot Number: 0025059139
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2020
• Initial Date Received by Manufacturer: 03/17/2020
• Supplement Date Received by Manufacturer: 04/28/2020
• Initial Report FDA Received Date: 03/31/2020
• Supplement Report FDA Received Date: 05/01/2020
• 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