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

Model Number	24700
Medical Device Problem Codes	Material Rupture (1546); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the moderately tortuous vessel in the upper limb.A 5.0mmx20mmx40cm (4f) sterling balloon catheter was advanced for dilatation.However, during the first inflation at 14 atmospheres, the balloon ruptured.The device was removed and the procedure was completed with a different device.There were no patient complications nor injuries reported.
Additional Manufacturer Narrative
(e1) initial reporter address 1: (b)(6).(f10) device code updated.
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the moderately tortuous vessel in the upper limb.A 5.0mmx20mmx40cm (4f) sterling balloon catheter was advanced for dilatation.However, during the first inflation at 14 atmospheres, the balloon ruptured.The device was removed and the procedure was completed with a different device.There were no patient complications nor injuries reported.It was further reported that this complaint was created in error as there was no alleged issue with the device.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9670159
• Report Number: 2134265-2020-00969
• Device Sequence Number: 11484213
• Product Code: DQY
• UDI-Device Identifier: 08714729122845
• UDI-Public: 08714729122845
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K053116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2020

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: 01/31/2020
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0020132109
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/16/2020
• Supplement Date Received by Manufacturer: 04/08/2020
• Initial Report FDA Received Date: 02/05/2020
• Supplement Report FDA Received Date: 04/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1