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	07/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.
Event or Problem Description
It was reported that a balloon rupture occurred.The 70% stenosed target lesion was located in the severely calcified superficial femoral artery (sfa).A 5.00 mm x 80 mm x 80 cm sterling balloon was used to dilate the target lesion, and on inflation at 4 to 6 atmospheres, the balloon ruptured.It was noted that the balloon rupture was due to the severely calcified lesion.The procedure was completed with another of the same device.No patient complications were reported in relation to this event and the patient condition following the procedure was stable.
Event or Problem Description
It was reported that a balloon rupture occurred.The 70% stenosed target lesion was located in the severely calcified superficial femoral artery (sfa).A 5.00 mm x 80 mm x 80 cm sterling balloon was used to dilate the target lesion, and on inflation at 4 to 6 atmospheres, the balloon ruptured.It was noted that the balloon rupture was due to the severely calcified lesion.The procedure was completed with another of the same device.No patient complications were reported in relation to this event and the patient condition following the procedure was stable.
Additional Manufacturer Narrative
Age at time of event: 18 years or older.Device evaluated by mfr: the shaft, hypotube, tip and balloon were microscopically and visually examined.There was contrast and blood in the inflation lumen and balloon.The balloon was loosely folded.There was a 9mm longitudinal tear 2mm from the distal end of the balloon.Inspection of the remainder of the device presented no other damage or irregularities.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8822513
• Report Number: 2134265-2019-08600
• Device Sequence Number: 19420244
• Product Code: DQY
• UDI-Device Identifier: 08714729122968
• UDI-Public: 08714729122968
• 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
• Report Date (Section B): 08/20/2019

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: 01/01/2022
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0023124261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2019
• Initial Date Received by Manufacturer: 07/03/2019
• Supplement Date Received by Manufacturer: 07/29/2019
• Initial Report FDA Received Date: 07/24/2019
• Supplement Report FDA Received Date: 08/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1