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

Model Number 24700

Device Problems Material Puncture/Hole (1504); Device-Device Incompatibility (2919)

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

Event Date 12/06/2021

Event Type  malfunction  

Event Description

It was reported that the balloon shaft was perforated.The 95% stenosed target lesion was located in the severely tortuous and mildly calcified cephalic vein.A 6.0mmx40mmx80cm (4f) sterling balloon catheter was advanced for dilatation.However, as the balloon was advanced along the guidewire, the guidewire protruded from the middle of the shaft.The procedure was completed with another of same device.There were no patient complications nor injuries reported.

Event Description

It was reported that the balloon shaft was perforated.The 95% stenosed target lesion was located in the severely tortuous and mildly calcified cephalic vein.A 6.0mmx40mmx80cm (4f) sterling balloon catheter was advanced for dilatation.However, as the balloon was advanced along the guidewire, the guidewire protruded from the middle of the shaft.The procedure was completed with another of same device.There were no patient complications nor injuries reported.

Manufacturer Narrative

Returned product consisted of a sterling balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual and microscopic examination revealed no damages.Device to device interaction was performed by tracking the device over a test guidewire.There were no issues tracking.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis could not confirm the difficulty to track over wire or hole in the device.

• 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: 13211864
• MDR Text Key: 283599062
• Report Number: 2134265-2021-16415
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 08714729123798
• UDI-Public: 08714729123798
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K053116
• 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,Followup
• Report Date: 02/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0027592902
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2021
• 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