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

Model Number	24700
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/08/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloon ruptured.During the procedure, it was noted that the 2.0 x 60 x 150, 4f sterling balloon ruptured during post dilation prior to reaching nominal pressure.The procedure was completed with another of the same device.No complications reported.
Event or Problem Description
It was reported that the balloon ruptured.During the procedure, it was noted that the 2.0 x 60 x 150, 4f sterling balloon ruptured during post dilation prior to reaching nominal pressure.The procedure was completed with another of the same device.No complications reported.It was further reported that the target lesion was a moderately tortuous and moderately calcified vessel.The balloon ruptured upon first inflation for 2-3 seconds and was removed over guidewire.The patient's condition post procedure was good.
Event or Problem Description
It was reported that the balloon ruptured.During the procedure, it was noted that the 2.0 x 60 x 150, 4f sterling balloon ruptured during post dilation prior to reaching nominal pressure.The procedure was completed with another of the same device.No complications reported.It was further reported that the target lesion was a moderately tortuous and moderately calcified vessel.The balloon ruptured upon first inflation for 2-3 seconds and was removed over guidewire.The patient's condition post procedure was good.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.There was a pinhole with scratch above distal marker.There was no other damage observed to the complaint 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: 9371162
• Report Number: 2134265-2019-14434
• Device Sequence Number: 16821500
• Product Code: LIT
• UDI-Device Identifier: 08714729859956
• UDI-Public: 08714729859956
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/21/2020

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 Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0023287906
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2019
• Initial Date Received by Manufacturer: 11/11/2019
• Supplement Date Received by Manufacturer: 11/11/2019; 12/30/2019
• Initial Report FDA Received Date: 11/25/2019
• Supplement Report FDA Received Date: 12/04/2019; 01/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1