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

Model Number	24690
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The patient presented with pulmonary hypertension.The stenosed target lesion was located in the pulmonary artery.A 4.0mmx30mmx135cm sterling balloon catheter was advanced to dilate the blood vessel to lower the pressure.However, during inflation, the balloon ruptured.The procedure was completed with another of the same device.There were no patient complications reported and the patient status was stable.
Event or Problem Description
It was reported that balloon rupture occurred.The patient presented with pulmonary hypertension.The stenosed target lesion was located in the pulmonary artery.A 4.0mmx30mmx135cm sterling balloon catheter was advanced to dilate the blood vessel to lower the pressure.However, during inflation, the balloon ruptured.The procedure was completed with another of the same device.There were no patient complications reported and the patient status was stable.It was further reported that the balloon ruptured on the first inflation at less working pressure for few seconds.
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 and microscopic examination revealed no damages.The balloon folds were still tightly folded and there is no contrast present inside the device.Functional testing was performed by inflating the device to rated burst pressure and it was able to hold pressure.
Event or Problem Description
It was reported that balloon rupture occurred.The patient presented with pulmonary hypertension.The stenosed target lesion was located in the pulmonary artery.A 4.0mmx30mmx135cm sterling balloon catheter was advanced to dilate the blood vessel to lower the pressure.However, during inflation, the balloon ruptured.The procedure was completed with another of the same device.There were no patient complications reported and the patient status was stable.It was further reported that the balloon ruptured on the first inflation at less working pressure for few seconds.

• 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: 12937049
• Report Number: 2134265-2021-15409
• Device Sequence Number: 17348397
• Product Code: DQY
• UDI-Device Identifier: 08714729756972
• UDI-Public: 08714729756972
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K141150
• 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,Followup
• Report Date (Section B): 01/28/2022

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: 11/02/2023
• Device Model Number: 24690
• Device Catalogue Number: 24690
• Device Lot Number: 0026284396
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/26/2021
• Supplement Date Received by Manufacturer: 12/07/2021; 01/14/2022
• Initial Report FDA Received Date: 12/06/2021
• Supplement Report FDA Received Date: 12/15/2021; 01/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2020
• 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: 65 YR
• Patient Sex: Male
• Patient Weight: 79 KG