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

Model Number 24716

Device Problem Material Integrity Problem (2978)

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

Event Date 12/29/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr.: the device was returned for analysis.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 guidewire lumen 21cm from the tip.Inspection of the remainder of the device presented no other damage or irregularities.

Event Description

Reportable based on device analysis completed on 11-feb-2021.It was reported that balloon damage occurred.The chronic totally occluded target lesion was located in the moderately calcified superficial femoral artery.A 6.0x220x150-hybrid sterling balloon catheter was advanced for dilation.However, on initial inflation under fluoroscopy, the balloon was twisting approximately 5cm from the proximal marker.The device was removed and the procedure was completed with another of the same device.No patient complications nor harm were reported.However, returned device analysis revealed shaft hole.

• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 11349787
• MDR Text Key: 232592149
• Report Number: 2134265-2021-01920
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08714729845485
• UDI-Public: 08714729845485
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132430
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/08/2021
• Device Model Number: 24716
• Device Catalogue Number: 24716
• Device Lot Number: 0025505981
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/11/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/12/2020
• 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