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

Model Number	24700
Medical Device Problem Codes	Material Rupture (1546); Detachment of Device or Device Component (2907); Material Integrity Problem (2978)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	08/30/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the tip detached.An 8.0mmx60mmx80cm sterling balloon was selected for a shunt procedure in the upper leg.During the procedure, the balloon was damaged during dilatation and the tip of the device detached.There were no reported patient complications.
Event or Problem Description
It was reported that the tip detached.An 8.0mmx60mmx80cm sterling balloon was selected for a shunt procedure in the upper leg.During the procedure, the balloon was damaged during dilatation and the tip of the device detached.There were no reported patient complications.It was further reported that when dilating the balloon, it suddenly burst.The balloon pressure was 13 millibars when it burst.Radiograph showed that a torn part of the balloon remained in the vessel.The physician was able to retrieve the detached piece of the balloon with a snare catheter.After removing the balloon, it was noted that the balloon had been torn circularly 5mm in front of the tip.There were no patient complications reported and the patient was discharged after the procedure.
Event or Problem Description
It was reported that the tip detached.An 8.0mmx60mmx80cm sterling balloon was selected for a shunt procedure in the upper leg.During the procedure, the balloon was damaged during dilatation and the tip of the device detached.There were no reported patient complications.It was further reported that when dilating the balloon, it suddenly burst.The balloon pressure was 13 millibars when it burst.Radiograph showed that a torn part of the balloon remained in the vessel.The physician was able to retrieve the detached piece of the balloon with a snare catheter.After removing the balloon, it was noted that the balloon had been torn circularly 5mm in front of the tip.There were no patient complications reported and the patient was discharged after the procedure.It was further reported that the balloon was inflated to 13 atmospheres not 13 millibars when the balloon burst.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9105401
• Report Number: 2134265-2019-11485
• Device Sequence Number: 19278311
• Product Code: DQY
• UDI-Device Identifier: 08714729720713
• UDI-Public: 08714729720713
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K053116
• 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): 07/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/06/2022
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0023450455
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/30/2019
• Supplement Date Received by Manufacturer: 11/29/2019; 06/25/2020
• Initial Report FDA Received Date: 09/23/2019
• Supplement Report FDA Received Date: 12/05/2019; 07/09/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention