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

Model Number	H74939148301510
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that there was a shaft break and inability to remove a fragment of the device.The 100% stenosed target lesion was located in the moderately tortuous and severely calcified superficial femoral artery (sfa).A 3.0mm x 150mm x 150cm fg sterling balloon catheter was advanced for dilation.However, the balloon was fractured in the distal portion of the balloon that contained that distal ro marker about 5-10 mm from the tip.The majority of the catheter was removed but the distal tip was stuck in the mid sfa.Physician attempted to snare the device out numerous times but was unable to retrieve it.The physician then proceeded with angioplasty, followed by placing a stent, and yet the piece was not moving or obstructing flow.After seeing the post angiogram result, patient had significant improvement in flow and the physician left the fractured piece of the balloon catheter.The procedure was completed with another of same device.There were no patient complications reported.
Additional Manufacturer Narrative
E1: initial reporter address 1: (b)(6).
Additional Manufacturer Narrative
This report is being filed to correct the model number and unique identifier (udi) # in response to an fda request.E1: initial reporter address 1: (b)(6).
Event or Problem Description
It was reported that there was a shaft break and inability to remove a fragment of the device.The 100% stenosed target lesion was located in the moderately tortuous and severely calcified superficial femoral artery (sfa).A 3.0mm x 150mm x 150cm fg sterling balloon catheter was advanced for dilation.However, the balloon was fractured in the distal portion of the balloon that contained that distal ro marker about 5-10 mm from the tip.The majority of the catheter was removed but the distal tip was stuck in the mid sfa.Physician attempted to snare the device out numerous times but was unable to retrieve it.The physician then proceeded with angioplasty, followed by placing a stent, and yet the piece was not moving or obstructing flow.After seeing the post angiogram result, patient had significant improvement in flow and the physician left the fractured piece of the balloon catheter.The procedure was completed with another of same device.There were no patient complications reported.

• Brand Name: STERLING SL
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• 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: 17889746
• Report Number: 2124215-2023-51196
• Device Sequence Number: 18030307
• Product Code: DQY
• UDI-Device Identifier: 08714729782315
• UDI-Public: (01)08714729782315(17)250511(10)31604444
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2024

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: 05/11/2025
• Device Model Number: H74939148301510
• Device Catalogue Number: 24703
• Device Lot Number: 0031604444
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/12/2023
• Supplement Date Received by Manufacturer: 06/12/2024
• Initial Report FDA Received Date: 10/06/2023
• Supplement Report FDA Received Date: 07/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2023
• 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