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

Model Number	24700
Medical Device Problem Codes	Material Rupture (1546); Material Deformation (2976)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon tear occurred.A 3.0x40x90 sterling balloon catheter was selected for use.However, when the balloon was taken out of the sterile packet, it was misshaped.The proximal part of the balloon was bent and part of the balloon was split opened.The procedure was completed with another of the same device.No patient complications were reported.
Event or Problem Description
It was reported that balloon rupture occurred.A 3.0x40x90 (4f) sterling balloon catheter was selected for use.However, when the balloon was taken out of the sterile packet and it was misshaped.He said the proximal part of the balloon was bent and part of the balloon was split open.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a sterling otw balloon catheter.Analysis of the tip, balloon and shaft included microscopic and visual inspection.Inspection revealed that the balloon was tightly folded until 43mm (from tip) and then the balloon was observed to be open/damaged.Inspection of the rest of the device found no other damage or defect.The reported balloon damage and bend were confirmed.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11019518
• Report Number: 2134265-2020-17936
• Device Sequence Number: 3823451
• Product Code: LIT
• UDI-Device Identifier: 08714729860143
• UDI-Public: 08714729860143
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K141112
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2021

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: 11/11/2021
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0025515749
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2021
• Initial Date Received by Manufacturer: 12/09/2020
• Supplement Date Received by Manufacturer: 01/26/2021
• Initial Report FDA Received Date: 12/16/2020
• Supplement Report FDA Received Date: 02/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1