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

Model Number	24690
Medical Device Problem Codes	Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a balloon rupture occurred.A 4.0mmx60mmx135cm sterling balloon catheter was selected for use in an angioplasty procedure in the right superficial femoral artery.The patient had stage iii peripheral chronic obliterative arteriopathy (aocp).During the procedure, the balloon ruptured.The device was removed, but upon exiting the introducer, there was a complete fracture of the balloon with the tip remaining inside the vessel with part of the balloon.It was indicated that the patient experienced prolonged procedural time.No further complications were reported.
Event or Problem Description
It was reported that a balloon rupture occurred.A 4.0mmx60mmx135cm sterling balloon catheter was selected for use in an angioplasty procedure in the right superficial femoral artery.The patient had stage iii peripheral chronic obliterative arteriopathy (aocp).During the procedure, the balloon ruptured.The device was removed, but upon exiting the introducer, there was a complete fracture of the balloon with the tip remaining inside the vessel with part of the balloon.It was indicated that the patient experienced prolonged procedural time.No further complications were reported.It was further reported that the target lesion had no severe stenosis and was located in a non-tortuous vessel with severely calcified segments.The balloon was inflated once at 8-10 atmospheres for two minutes.The balloon ruptured on this first inflation.The balloon was removed as soon as it was noted to broken.Once it was outside the patient's body, it was observed that the balloon tip was missing.The physician tried to remove the guidewire together with the introducer sheath with the hope that the balloon tip was stuck within the introducer sheath.No additional intervention was performed in an attempt to retrieve the balloon tip because the physician was not sure where the balloon tip was.The device fragment was not visible under fluoroscopy imaging.Without the guidewire and introducer sheath in place, the procedure was ended with arterial compression.The patient's current status is good.No additional complications were observed.
Additional Manufacturer Narrative
Device eval by manufacturer: returned product consisted of a sterling balloon catheter.The outer shaft, inner shaft, balloon, and tip were visually and microscopically examined.Visual examination revealed that the balloon was separated 138.8cm from the hub and the guidewire lumen was separated 132cm from the hub.Microscopic examination revealed no additional damages.The tip, distal section of the balloon, and distal section of the guidewire lumen did not return for analysis.
Event or Problem Description
It was reported that a balloon rupture occurred.A 4.0mmx60mmx135cm sterling balloon catheter was selected for use in an angioplasty procedure in the right superficial femoral artery.The patient had stage iii peripheral chronic obliterative arteriopathy (aocp).During the procedure, the balloon ruptured.The device was removed, but upon exiting the introducer, there was a complete fracture of the balloon with the tip remaining inside the vessel with part of the balloon.It was indicated that the patient experienced prolonged procedural time.No further complications were reported.It was further reported that the target lesion had no severe stenosis and was located in a non-tortuous vessel with severely calcified segments.The balloon was inflated once at 8-10 atmospheres for two minutes.The balloon ruptured on this first inflation.The balloon was removed as soon as it was noted to broken.Once it was outside the patient's body, it was observed that the balloon tip was missing.The physician tried to remove the guidewire together with the introducer sheath with the hope that the balloon tip was stuck within the introducer sheath.No additional intervention was performed in an attempt to retrieve the balloon tip because the physician was not sure where the balloon tip was.The device fragment was not visible under fluoroscopy imaging.Without the guidewire and introducer sheath in place, the procedure was ended with arterial compression.The patient's current status is good.No additional complications were observed.

• 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: 16754792
• Report Number: 2124215-2023-17425
• Device Sequence Number: 11582372
• Product Code: DQY
• UDI-Device Identifier: 08714729757016
• UDI-Public: 08714729757016
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/06/2025
• Device Model Number: 24690
• Device Catalogue Number: 24690
• Device Lot Number: 0030665148
• 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: 03/22/2023
• Supplement Date Received by Manufacturer: 04/27/2023; 07/19/2023
• Initial Report FDA Received Date: 04/17/2023
• Supplement Report FDA Received Date: 05/24/2023; 08/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown