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

Model Number 24700

Device Problem Failure to Deflate (4060)

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

Event Date 12/08/2022

Event Type  malfunction  

Event Description

It was reported that balloon deflation issue occurred.The target lesion was located in a shunt in the moderately tortuous vessel.A 5.0mmx100mmx80cm (4f) sterling balloon catheter was advanced for dilation.However, during the procedure, deflation trouble was encountered.The indeflator was used to deflate the balloon in an inflated state.The patient did not have any symptoms while the balloon remained inflated.The catheter was removed with no patient complications nor injuries were reported.

Event Description

It was reported that balloon deflation issue occurred.The target lesion was located in a shunt in the moderately tortuous vessel.A 5.0mmx100mmx80cm (4f) sterling balloon catheter was advanced for dilation.However, during the procedure, deflation trouble was encountered.The indeflator was used to deflate the balloon in an inflated state.The patient did not have any symptoms while the balloon remained inflated.The catheter was removed with no patient complications nor injuries were reported.

Manufacturer Narrative

Device evaluated by mfr.: returned product consisted of a sterling balloon catheter stuck inside a merit 6f sheath.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed that the shaft us stretched 11.2cm and 16.5cm from the tip.Microscopic examination revealed no additional damages.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis found damage to the device that could have contributed to the reported event.

• 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: 16025910
• MDR Text Key: 306803409
• Report Number: 2124215-2022-53017
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 08714729122821
• UDI-Public: 08714729122821
• 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: 02/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2022
• 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: 0030134913
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/20/2022
• 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