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

Model Number	24715
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/25/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the superficial femoral artery.Two 6.0x120x150-hybrid sterling balloon catheters were advanced for dilatation.However, both balloons ruptured upon initial inflation.The procedure was completed with another of the same device.No patient complications nor injuries were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.:returned product consisted of a sterling balloon catheter.The balloon was loosely folded, and the device was bloody.Analysis of the tip, balloon, markerbands, inner/outer shaft included microscopic and visual inspection.Inspection revealed a hole in the balloon material that was 1mm distal to the proximal markerband.The edges of the hole were jagged/irregular in shape.Inspection of the rest of the rest of the device found no other damage or defect.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the superficial femoral artery.Two 6.0x120x150-hybrid sterling balloon catheters were advanced for dilatation.However, both balloons ruptured upon initial inflation.The procedure was completed with another of the same device.No patient complications nor injuries 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: 9310651
• Report Number: 2134265-2019-13712
• Device Sequence Number: 380449
• Product Code: LIT
• UDI-Device Identifier: 08714729845423
• UDI-Public: 08714729845423
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K132430
• 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): 12/02/2019

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: 10/19/2020
• Device Model Number: 24715
• Device Catalogue Number: 24715
• Device Lot Number: 0023678950
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2019
• Initial Date Received by Manufacturer: 10/25/2019
• Supplement Date Received by Manufacturer: 11/21/2019
• Initial Report FDA Received Date: 11/12/2019
• Supplement Report FDA Received Date: 12/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1