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

Model Number	24700
Medical Device Problem Codes	Inflation Problem (1310); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon difficult to remove occurred.A 5.0mmx100mmx135cm (4f) sterling balloon catheter was advanced for dilatation, however, during the procedure the balloon failed to inflate.The doctor had to pull the whole system out including the sheath and it had to be cut to get the sheath off the wire.The procedure was completed with a different device.There were no patient complications reported.
Additional 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 that the inflation lumen and guidewire lumen is stretched in multiple locations.The guidewire lumen is separated 156.1cm from the hub.The balloon is separated 156.6cm from the hub.Microscopic examination revealed no additional damages.The distal end of the separation with the tip is missing.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis found damage that would have contributed to the difficulty to remove and failure to inflate.
Event or Problem Description
It was reported that balloon difficult to remove occurred.A 5.0mmx100mmx135cm (4f) sterling balloon catheter was advanced for dilatation, however, during the procedure the balloon failed to inflate.The doctor had to pull the whole system out including the sheath and it had to be cut to get the sheath off the wire.The procedure was completed with a different device.There were no patient complications reported.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17436033
• Report Number: 2124215-2023-40640
• Device Sequence Number: 12982921
• Product Code: DQY
• UDI-Device Identifier: 08714729122814
• UDI-Public: 08714729122814
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K053116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/29/2025
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0030256582
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/10/2023
• Supplement Date Received by Manufacturer: 08/23/2023
• Initial Report FDA Received Date: 08/01/2023
• Supplement Report FDA Received Date: 09/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown