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	05/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the calcified superficial femoral artery.A 6.0mmx220mmx150cm (4f) sterling balloon catheter was advanced for dilatation.First inflation was performed; however, during second inflation, dilation could not be performed.Inflation device pressure was applied, but pressure could not be applied.The device was removed, and inflation was performed outside the patient's body, but pressure still could not be applied.Since it was a calcified lesion, there was a possibility that the balloon ruptured.The procedure was completed with a different device.No patient complications were reported.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the calcified superficial femoral artery.A 6.0mmx220mmx150cm (4f) sterling balloon catheter was advanced for dilatation.First inflation was performed; however, during second inflation, dilation could not be performed.Inflation device pressure was applied, but pressure could not be applied.The device was removed, and inflation was performed outside the patient's body, but pressure still could not be applied.Since it was a calcified lesion, there was a possibility that the balloon ruptured.The procedure was completed with a different device.No patient complications were reported.It was further reported that the target lesion has 90% stenosed, not tortuous and moderately calcified.
Additional Manufacturer Narrative
E1 initial reporter city: (b)(6).
Additional Manufacturer Narrative
E1 initial reporter city: (b)(6).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 loosely folded and there is contrast present inside the device.Functional testing was performed by inflating the device to rated burst pressure and it was able to hold pressure.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the calcified superficial femoral artery.A 6.0mmx220mmx150cm (4f) sterling balloon catheter was advanced for dilatation.First inflation was performed; however, during second inflation, dilation could not be performed.Inflation device pressure was applied, but pressure could not be applied.The device was removed, and inflation was performed outside the patient's body, but pressure still could not be applied.Since it was a calcified lesion, there was a possibility that the balloon ruptured.The procedure was completed with a different device.No patient complications were reported.It was further reported that the target lesion has 90% stenosed, not tortuous and moderately calcified.

• 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: 14365180
• Report Number: 2134265-2022-05454
• Device Sequence Number: 1970471
• Product Code: LIT
• UDI-Device Identifier: 08714729859659
• UDI-Public: 08714729859659
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 06/10/2022

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: 03/02/2024
• Device Model Number: 24690
• Device Catalogue Number: 24690
• Device Lot Number: 0026903665
• 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: 05/09/2022
• Supplement Date Received by Manufacturer: 05/25/2022; 06/04/2022
• Initial Report FDA Received Date: 05/11/2022
• Supplement Report FDA Received Date: 05/31/2022; 06/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2021
• 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 Sex: Unknown