MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION STERLING SL; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	24703
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 2.5mm stenosed target lesion was located in the non- tortuous and mildly calcified femoral vein.A 3.0mm x 150mm x 150cm sterling sl balloon catheter was advanced for dilation.The physician attempted to inflate the balloon twice at 8 atmospheres (atm) but failed, the device was then removed and re-entered into the lesion site.The balloon was partially inflated at 8 atm.So, the physician increased the atmospheres to 10 atm, the balloon was fully deployed after 5-10 minutes.The device was removed and was introduced into another lesion to inflate again.However, during inflation at 8 atmospheres, the balloon ruptured.The device was simply pulled out and the procedure was completed with another of same device.There were no patient complications reported and the patient status was stable.
Event or Problem Description
It was reported that balloon rupture occurred.The 2.5mm stenosed target lesion was located in the non- tortuous and mildly calcified femoral vein.A 3.0mm x 150mm x 150cm sterling sl balloon catheter was advanced for dilation.The physician attempted to inflate the balloon twice at 8 atmospheres (atm) but failed, the device was then removed and re-entered into the lesion site.The balloon was partially inflated at 8 atm.So, the physician increased the atmospheres to 10 atm, the balloon was fully deployed after 5-10 minutes.The device was removed and was introduced into another lesion to inflate again.However, during inflation at 8 atmospheres, the balloon ruptured.The device was simply pulled out and the procedure was completed with another of same device.There were no patient complications reported and the patient status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a sterling sl balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed that the guidewire lumen is prolapsed 4.2cm from the tip.Microscopic examination revealed a hole in the guidewire lumen at the prolapse.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed there is a hole in the guidewire lumen.

• Brand Name: STERLING SL
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• 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: 15291024
• Report Number: 2124215-2022-32315
• Device Sequence Number: 11335735
• Product Code: DQY
• UDI-Device Identifier: 08714729782315
• UDI-Public: 08714729782315
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K093720
• 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): 10/07/2022

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: 02/10/2024
• Device Model Number: 24703
• Device Catalogue Number: 24703
• Device Lot Number: 0028843074
• 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: 08/15/2022
• Supplement Date Received by Manufacturer: 10/04/2022
• Initial Report FDA Received Date: 08/25/2022
• Supplement Report FDA Received Date: 10/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2022
• 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: 74 YR
• Patient Sex: Female
• Patient Weight: 62 KG