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

Model Number 24716

Device Problem Inflation Problem (1310)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/27/2023

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of a sterling balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed no damages.Microscopic examination revealed a pinhole in the balloon 90mm from the tip.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis found a pinhole in the balloon.

Event Description

Reportable based on device analysis completed on 07-mar-2023.It was reported that balloon inflation issues occurred.The patient underwent lower limb angioplasty.The 60-80% stenosed target lesion was located in the severely calcified and moderately tortuous superficial femoral artery and/or popliteal region.A 5.0x220x150-hybrid sterling balloon catheter was advanced for dilation but when inflating the balloon, it could not be fully inflated to nominal atmospheres.Physician tried twice and same thing happen.The balloon was withdrawn, and the procedure was completed with another 5mmx 220mm 90cm sterling balloon catheter.No patient complications were reported.However, returned device analysis revealed balloon pinhole.

• Brand Name: STERLING
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16631917
• MDR Text Key: 312211236
• Report Number: 2124215-2023-11325
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08714729845409
• UDI-Public: 08714729845409
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K132430
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 24716
• Device Catalogue Number: 24716
• Device Lot Number: 0029002479
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2022
• 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 Race: Asian