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

Model Number	24716
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/27/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a portion of the balloon became separated and remained in the patient.A 4f 3mm x 220mm x 150cm sterling was selected for use in a balloon angioplasty procedure.During the procedure post dilation, the balloon was deflated and removed from the patient.It was then discovered that a portion of the balloon had separated and remained in the patient.Attempts were made to retrieve the device fragment, but they were unsuccessful.The procedure was completed with a covered stent.The patient was fine and in stable condition.
Additional Manufacturer Narrative
Device eval by mfr: returned product consisted of a sterling balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There was contrast and blood in the inflation lumen and balloon, and blood in the guidewire lumen.The balloon was loosely folded.There was a circumferential tear 12.4cm from the proximal end of the balloon.The inner shaft was separated at the tack weld 123.6cm from the strain relief.There was a section of inner shaft with the device that was severely buckled and stretched and could not be accurately measured.The distal portion of the balloon, tip, and part of the inner shaft was missing.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that a portion of the balloon became separated and remained in the patient.A 4f 3mm x 220mm x 150cm sterling was selected for use in a balloon angioplasty procedure.During the procedure post dilation, the balloon was deflated and removed from the patient.It was then discovered that a portion of the balloon had separated and remained in the patient.Attempts were made to retrieve the device fragment, but they were unsuccessful.The procedure was completed with a covered stent.The patient was fine and in stable condition.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11318763
• Report Number: 2134265-2021-01576
• Device Sequence Number: 11596936
• Product Code: LIT
• UDI-Device Identifier: 08714729860174
• UDI-Public: 08714729860174
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K141112
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2021

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: 04/30/2022
• Device Model Number: 24716
• Device Catalogue Number: 24716
• Device Lot Number: 0026282291
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2021
• Initial Date Received by Manufacturer: 01/28/2021
• Supplement Date Received by Manufacturer: 03/18/2021
• Initial Report FDA Received Date: 02/11/2021
• Supplement Report FDA Received Date: 04/08/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention