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

Model Number 24702

Device Problems Material Rupture (1546); Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 11/25/2021

Event Type  Injury  

Event Description

It was reported that balloon rupture and tip detachment occurred.A 2.5x220x150 (4f) sterling balloon catheter was advanced for dilatation.However, during the procedure, the balloon burst horizontally and the tip of the balloon separated within the vessel.Endarterectomy was performed to retrieve the balloon tip.No further complications were reported.

Event Description

It was reported that balloon rupture and tip detachment occurred.A 2.5x220x150 (4f) sterling balloon catheter was advanced for dilatation.However, during the procedure, the balloon burst horizontally and the tip of the balloon separated within the vessel.Endarterectomy was performed to retrieve the balloon tip.No further complications were reported.It was further reported that the balloon was inflated once and ruptured at 14 atmospheres.The patient status was stable.

Event Description

It was reported that balloon rupture and tip detachment occurred.A 2.5x220x150 (4f) sterling balloon catheter was advanced for dilatation.However, during the procedure, the balloon burst horizontally and the tip of the balloon separated within the vessel.Endarterectomy was performed to retrieve the balloon tip.No further complications were reported.It was further reported that the balloon was inflated once and ruptured at 14 atmospheres.The patient status was stable.It was further reported that the correct device size was 3x100x150mm and not a 2.5x220x150 as previously reported.

• Brand Name: STERLING SL
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC SCIMED, INC
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12987198
• MDR Text Key: 282198899
• Report Number: 2134265-2021-15508
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K093720
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 24702
• Device Catalogue Number: 24702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2022
• 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