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	10/29/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloon ruptured.An 8.0mmx40mmx80cm sterling balloon catheter was selected for a percutaneous transluminal angioplasty of a calcified vessel.During the procedure inside the patient, the balloon ruptured.The procedure was completed with another sterling balloon catheter.There were no patient complications reported and the patient was stable post procedure.
Event or Problem Description
It was reported that the balloon ruptured.An 8.0mmx40mmx80cm sterling balloon catheter was selected for a percutaneous transluminal angioplasty (pta) of a calcified vessel.During the procedure inside the patient, the balloon ruptured.The procedure was completed with another sterling balloon catheter.There were no patient complications reported and the patient was stable post procedure.Additional information reported that the pta was of a diffuse and calcific lesion with different morphology.The balloon ruptured at 8 atm during pta of the iliac artery.The physician was able to withdraw the device from the patient.The patient was discharged after the procedure.
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of a sterling balloon catheter.Microscopic examination of the device revealed a 2mm tear in the balloon material in the center of the balloon.The reported balloon burst was confirmed.
Event or Problem Description
It was reported that the balloon ruptured.An 8.0mmx40mmx80cm sterling balloon catheter was selected for a percutaneous transluminal angioplasty (pta) of a calcified vessel.During the procedure inside the patient, the balloon ruptured.The procedure was completed with another sterling balloon catheter.There were no patient complications reported and the patient was stable post procedure.Additional information reported that the pta was of a diffuse and calcific lesion with different morphology.The balloon ruptured at 8 atm during pta of the iliac artery.The physician was able to withdraw the device from the patient.The patient was discharged after the procedure.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9327931
• Report Number: 2134265-2019-13849
• Device Sequence Number: 11387289
• Product Code: DQY
• UDI-Device Identifier: 08714729720690
• UDI-Public: 08714729720690
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 01/03/2020

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: 0024164187
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2019
• Initial Date Received by Manufacturer: 11/05/2019
• Supplement Date Received by Manufacturer: 11/18/2019; 12/30/2019
• Initial Report FDA Received Date: 11/15/2019
• Supplement Report FDA Received Date: 11/22/2019; 01/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1