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

Model Number	24700
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon deflation failure occurred.The 90% stenosed target lesion was located in the moderately tortuous pulmonary artery.A 10.0mmx20mmx80cm sterling balloon catheter was advanced for dilation.However, it was noted that the balloon was unable to deflate completely, but it seemed that it was able to deflate when pulled out.The device was removed intact and the procedure was completed with another of same device.There were no patient complications reported.
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that balloon deflation failure occurred.The 90% stenosed target lesion was located in the moderately tortuous pulmonary artery.A 10.0mmx20mmx80cm sterling balloon catheter was advanced for dilation.However, it was noted that the balloon was unable to deflate completely, but it seemed that it was able to deflate when pulled out.The device was removed intact and the procedure was completed with another of same device.There were no patient complications reported.
Additional Manufacturer Narrative
E1: initial reporter address 1: (b)(6).Device evaluated by manufacturer: returned product consisted of a sterling balloon catheter with an unknown sheath.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed that the inflation lumen is stretched 7.2cm 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
• Common Device Name: 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: 13010576
• Report Number: 2134265-2021-15477
• Device Sequence Number: 4926659
• Product Code: DQY
• UDI-Device Identifier: 08714729123415
• UDI-Public: 08714729123415
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/01/2024
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0026896508
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/30/2021
• Supplement Date Received by Manufacturer: 01/14/2022
• Initial Report FDA Received Date: 12/15/2021
• Supplement Report FDA Received Date: 02/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2021
• 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 Age: 35 YR
• Patient Sex: Female