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 inside the patient.An 8.0mmx40mmx80cm sterling balloon was selected for use in a percutaneous transluminal angioplasty procedure of the iliac artery.The lesion in the iliac artery was described as diffuse and calcified with a different morphology.During the procedure, the balloon was inflated to 8 atmospheres of pressure when it ruptured.The physician was able to withdraw the balloon.A new balloon of the same model was used to complete the procedure.The patient was not harmed.No adverse effects were reported and the patient was discharged after the procedure.
Event or Problem Description
It was reported that the balloon ruptured inside the patient.An 8.0mmx40mmx80cm sterling balloon was selected for use in a percutaneous transluminal angioplasty procedure of the iliac artery.The lesion in the iliac artery was described as diffuse and calcified with a different morphology.During the procedure, the balloon was inflated to 8 atmospheres of pressure when it ruptured.The physician was able to withdraw the balloon.A new balloon of the same model was used to complete the procedure.The patient was not harmed.No adverse effects were reported and the patient was discharged after the procedure.
Additional Manufacturer Narrative
Device analysis by mfr: the returned product consisted of a sterling balloon catheter.The balloon was torn longitudinally 26mm distal end of the balloon.There was no other damage identified.The reported balloon burst was confirmed.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9341797
• Report Number: 2134265-2019-13959
• Device Sequence Number: 14009486
• 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
• 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 Expiration Date: 06/27/2022
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0024028385
• 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: 12/30/2019
• Initial Report FDA Received Date: 11/19/2019
• Supplement Report FDA Received Date: 01/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1