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

Model Number	24715
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The more than 80% stenosed target lesion was located in the moderately tortuous and severely calcified vessel.During the procedure, the physician tried to advance an 035" x 135cm rubicon over the bifurcation, but the catheter would not advance due to a major kink in it.After placing a 45cm sheath, another 035" x 135cm rubicon was opened and successfully used to cross over the supported bifurcation.The procedure continued with atherectomy of the mid and distal sfa, and popliteal arteries using rotablator.A 5mm x 150mm x 150 cm steriling balloon was inserted and advanced to the popliteal - mid sfa lesion without issue.However, during the first inflation at 6 atmospheres for few seconds, the balloon ruptured.The device was removed and the procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the complaint device was received for product analysis.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 16mm 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.
Event or Problem Description
It was reported that balloon rupture occurred.The more than 80% stenosed target lesion was located in the moderately tortuous and severely calcified vessel.During the procedure, the physician tried to advance an 035" x 135cm rubicon over the bifurcation, but the catheter would not advance due to a major kink in it.After placing a 45cm sheath, another 035" x 135cm rubicon was opened and successfully used to cross over the supported bifurcation.The procedure continued with atherectomy of the mid and distal sfa, and popliteal arteries using rotablator.A 5mm x 150mm x 150 cm steriling balloon was inserted and advanced to the popliteal - mid sfa lesion without issue.However, during the first inflation at 6 atmospheres for few seconds, the balloon ruptured.The device was removed and the procedure was completed with another of the same device.No patient complications were reported.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19011304
• Report Number: 2124215-2024-19239
• Device Sequence Number: 19785636
• Product Code: LIT
• UDI-Device Identifier: 08714729845362
• UDI-Public: 08714729845362
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K132430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2024

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: 02/28/2026
• Device Model Number: 24715
• Device Catalogue Number: 24715
• Device Lot Number: 0031143641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/21/2024
• Supplement Date Received by Manufacturer: 04/17/2024
• Initial Report FDA Received Date: 04/01/2024
• Supplement Report FDA Received Date: 04/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2023
• 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: 75 YR
• Patient Sex: Male
• Patient Race: White