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

Model Number	24690
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The patient was presented with intra-stent restenosis in c1 segment and underwent arterial balloon dilation and a stent implantation.The 95% stenosed target lesion was located in the right internal carotid artery.An 8f boston scientific (bsc) guide catheter was engaged and a filterwire ez guidewire was crossed the lesion.A 4.0mmx30mmx135cm (4f) sterling balloon catheter was advanced for pre-dilatation.During the procedure, the balloon was dilated at 5 atmospheres (atm); however, the physician noticed that the balloon cannot be dilated any further and the pressure was decreasing.The device was removed from the patient by normal operation and found that the balloon has ruptured.Pre-dilation was completed with another of same device and the stent implantation was completed normally.There were no complications and injuries reported and the patient was fine and stable.
Event or Problem Description
It was reported that balloon rupture occurred.The patient was presented with intra-stent restenosis in c1 segment and underwent arterial balloon dilation and a stent implantation.The 95% stenosed target lesion was located in the right internal carotid artery.An 8f boston scientific (bsc) guide catheter was engaged and a filterwire ez guidewire was crossed the lesion.A 4.0mmx30mmx135cm (4f) sterling balloon catheter was advanced for pre-dilatation.During the procedure, the balloon was dilated at 5 atmospheres (atm); however, the physician noticed that the balloon cannot be dilated any further and the pressure was decreasing.The device was removed from the patient by normal operation and found that the balloon has ruptured.Pre-dilation was completed with another of same device and the stent implantation was completed normally.There were no complications and injuries reported and the patient was fine and stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a sterling balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed no damages.Microscopic examination revealed a pinhole in the balloon 24mm from the tip.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed there is a pinhole in the balloon.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15939671
• Report Number: 2124215-2022-51298
• Device Sequence Number: 20419759
• Product Code: DQY
• UDI-Device Identifier: 08714729756972
• UDI-Public: 08714729756972
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K141150
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2023

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: 07/28/2025
• Device Model Number: 24690
• Device Catalogue Number: 24690
• Device Lot Number: 0029858224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/30/2022
• Supplement Date Received by Manufacturer: 03/07/2023
• Initial Report FDA Received Date: 12/08/2022
• Supplement Report FDA Received Date: 03/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 76 KG