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	06/18/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occured.The target lesion was located in the vessel of the left leg.A 7.0mm x 40mm x 135cm sterling balloon catheter was advanced for dilation.However, during inflation at 2 psi, the balloon ruptured.The device was removed and upon trying to inflate the balloon, a hole was noted.The procedure was completed with anther of the same device.No patient complications were reported.
Event or Problem Description
It was reported that balloon rupture occured.The target lesion was located in the vessel of the left leg.A 7.0mm x 40mm x 135cm sterling balloon catheter was advanced for dilation.However, during inflation at 2 psi, the balloon ruptured.The device was removed and upon trying to inflate the balloon, a hole was noted.The procedure was complerted with anther of the same device.No patient commplcaitions were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product was a sterling otw catheter.The balloon was loosely folded with blood in the balloon and wire lumen.The tip, balloon, inner/outer shaft were microscopically and visually inspected.Inspection revealed a small balloon burst (circumferential) that was approximately 1mm in length with abrasions around the burst area.The location of the burst and abrasions was 3mm distal of the proximal markerband.The rest of the device was inspected, and no other damage or irregularities were found.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8760231
• Report Number: 2134265-2019-07753
• Device Sequence Number: 19167996
• Product Code: DQY
• UDI-Device Identifier: 08714729124078
• UDI-Public: 08714729124078
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K053116
• 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): 08/06/2019

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: 07/14/2021
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0022377802
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2019
• Initial Date Received by Manufacturer: 06/21/2019
• Supplement Date Received by Manufacturer: 07/26/2019
• Initial Report FDA Received Date: 07/03/2019
• Supplement Report FDA Received Date: 08/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1