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

Model Number 24703

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/12/2023

Event Type  Injury  

Event 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.

Manufacturer Narrative

E1: initial reporter address 1: (b)(6).

• Brand Name: STERLING SL
• Type of Device: 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
• MDR Text Key: 325140282
• Report Number: 2124215-2023-51196
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 08714729782315
• UDI-Public: 08714729782315
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093720
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 24703
• Device Catalogue Number: 24703
• Device Lot Number: 0031604444
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention