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

Model Number 24700

Device Problem Difficult to Insert (1316)

Patient Problems Foreign Body In Patient (2687); Thrombosis/Thrombus (4440)

Event Date 02/01/2024

Event Type  Injury  

Manufacturer Narrative

B3: date of event - used the first date of the month of the aware date as no event date was provided.

Event Description

It was reported that the balloon loading tool was inadvertently left in the patient.The patient presented with a thrombosed arteriovenous fistula (avf) and underwent thrombolysis and angioplasty.Ultrasound revealed that a long and tubular foreign body was in the avf from a previous procedure.The foreign body was believed to be a balloon cover of a 4.0mmx100mmx80cm sterling balloon catheter which was accidentally pushed into the introducer sheath and into the blood vessel.A guidewire and balloon were used to push the foreign body out of the vessel and treat the thrombosed avf.The procedure was completed, and the patient was fully recovered.

• Brand Name: STERLING
• Type of Device: 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: 18768643
• MDR Text Key: 336122452
• Report Number: 2124215-2024-09993
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K053116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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