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	07/26/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that balloon rupture and detachment occurred.The target lesion was located in the moderately tortuous and moderately to severely calcified celiac artery.A 4.0mmx20mmx135cm (4f) sterling balloon catheter was advanced for dilation.However, during initial inflation at nominal pressure, the balloon ruptured.The catheter was withdrawn; but the distal portion of the balloon including both radio opaque markers were still visible in the lesion when inspected under fluoroscopy.The physician tried to snare the detached potion of the device from the lesion but was unsuccessful.Eventually, a non-boston scientific self-expanding stent was used to cover the detached device and completed the procedure successfully.No patient complications were reported.
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 that the guidewire lumen is separated 136.4cm from the hub.The balloon is separated 141cm from the hub.Microscopic examination revealed no additional damages.The tip, marker bands, distal section of the guidewire lumen and distal section of the balloon were not returned.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis found confirmed the reported separation.
Event or Problem Description
It was reported that balloon rupture and detachment occurred.The target lesion was located in the moderately tortuous and moderately to severely calcified celiac artery.A 4.0mmx20mmx135cm (4f) sterling balloon catheter was advanced for dilation.However, during initial inflation at nominal pressure, the balloon ruptured.The catheter was withdrawn; but the distal portion of the balloon including both radio opaque markers were still visible in the lesion when inspected under fluoroscopy.The physician tried to snare the detached potion of the device from the lesion but was unsuccessful.Eventually, a non-boston scientific self-expanding stent was used to cover the detached device and completed the procedure successfully.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: 17558764
• Report Number: 2124215-2023-41100
• Device Sequence Number: 3454488
• Product Code: DQY
• UDI-Device Identifier: 08714729756958
• UDI-Public: 08714729756958
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K141150
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 09/28/2023

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: 05/16/2026
• Device Model Number: 24690
• Device Catalogue Number: 24690
• Device Lot Number: 0031633606
• 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: 07/26/2023
• Supplement Date Received by Manufacturer: 09/07/2023
• Initial Report FDA Received Date: 08/16/2023
• Supplement Report FDA Received Date: 09/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown