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

Model Number 24700

Device Problems Deflation Problem (1149); Inflation Problem (1310)

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

Event Date 03/31/2022

Event Type  malfunction  

Event Description

It was reported that deflation failure occurred.The target lesion was located in left cephalic vein.A 5.0mmx40mmx135cm sterling balloon catheter was advanced for dilation.The balloon was held to 10 atmospheres, however, it would not inflate.When it was removed from the body, it was noted to be fully deflated and when attempted to inflate outside the body, it did finally inflate, but it would not deflate at all.The procedure was completed with a 5x40 non-boston scientific device.There were no patient complications nor injuries reported.

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.The catheter batch number is a match to the complaint batch number.Visual examination showed a kink 95 cm from the hub.Microscopic examination revealed a kink at the marker band under the balloon.The device was inflated but it took about a minute to fully inflate.When deflating the device it took approximate 1 minute.The account may not have been in a position to wait for the device to deflate.Device analysis determined the condition of the returned device was not consistent with the reported information of failure to inflate and failure to deflate.

Event Description

It was reported that deflation failure occurred.The target lesion was located in left cephalic vein.A 5.0mmx40mmx135cm sterling balloon catheter was advanced for dilation.The balloon was held to 10 atmospheres, however, it would not inflate.When it was removed from the body, it was noted to be fully deflated and when attempted to inflate outside the body, it did finally inflate, but it would not deflate at all.The procedure was completed with a 5x40 non-boston scientific device.There were no patient complications nor injuries reported.

• 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: 14187128
• MDR Text Key: 289894374
• Report Number: 2134265-2022-04072
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 08714729122906
• UDI-Public: 08714729122906
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K053116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/25/2024
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0026870913
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/31/2022
• Initial Date FDA Received: 04/22/2022
• Supplement Dates Manufacturer Received: 05/05/2022
• Supplement Dates FDA Received: 05/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2021
• 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
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Race: White