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	03/11/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The stenosed lesion was located in superficial femoral artery.A 5.0 x 150 x 150 hybrid fg sterling otw balloon catheter was advanced for dilation and ruptured in the superficial femoral artery.The device was removed and the procedure completed with another of the same.No patient complications were reported and the patient status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis.Device analysis revealed the tip, balloon, markerbands, proximal bond, and inner, outer shaft were microscopically and visually inspected.Inspection revealed a pinhole in the balloon material located 6cm from the tip of the device.Inspection of the remaining device found no other damage or irregularities.
Event or Problem Description
It was reported that balloon rupture occurred.The stenosed lesion was located in superficial femoral artery.A 5.0 x 150 x 150 hybrid fg sterling otw balloon catheter was advanced for dilation and ruptured in the superficial femoral artery.The device was removed and the procedure completed with another of the same.No patient complications were reported and the patient status was stable.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8457418
• Report Number: 2134265-2019-02946
• Device Sequence Number: 354775
• Product Code: LIT
• UDI-Device Identifier: 08714729845362
• UDI-Public: 08714729845362
• 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): 05/17/2019

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: 07/12/2020
• Device Model Number: 24715
• Device Catalogue Number: 24715
• Device Lot Number: 0023181262
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2019
• Initial Date Received by Manufacturer: 03/11/2019
• Supplement Date Received by Manufacturer: 04/30/2019
• Initial Report FDA Received Date: 03/27/2019
• Supplement Report FDA Received Date: 05/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1