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

Model Number	24690
Medical Device Problem Codes	Material Rupture (1546); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon pinhole occurred.The 95% stenosed, 6mm target lesion was located in the moderately tortuous and severely calcified superficial femoral artery.Pre-inflation was performed with a 3mm balloon.After the non-boston scientific guidewire was crossed to the lesion, a 5.0mmx220mmx150cm (4f) sterling balloon catheter was advanced for dilatation.However, during the first inflation at 10 atmospheres for 30 seconds, the balloon twisted.The device was removed.In an attempt to fix the twisted balloon outside of the patient, the guidewire was advanced in and out of the balloon resulting in the guidewire penetrating through the balloon.The procedure was completed with a different device.There were no patient complications nor injuries reported.
Additional Manufacturer Narrative
Initial reporter city: (b)(6).
Additional Manufacturer Narrative
Initial reporter city: (b)(6).
Event or Problem Description
It was reported that balloon pinhole occurred.The 95% stenosed, 6mm target lesion was located in the moderately tortuous and severely calcified superficial femoral artery.Pre-inflation was performed with a 3mm balloon.After the non-boston scientific guidewire was crossed to the lesion, a 5.0mmx220mmx150cm (4f) sterling balloon catheter was advanced for dilatation.However, during the first inflation at 10 atmospheres for 30 seconds, the balloon twisted.The device was removed.In an attempt to fix the twisted balloon outside of the patient, the guidewire was advanced in and out of the balloon resulting in the guidewire penetrating through the balloon.The procedure was completed with a different device.There were no patient complications nor injuries reported.
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 examination revealed no damages.Microscopic examination revealed a hole in the shaft 10.2cm from the hub.The device was functionally tested by inflating it but the device was leaking from the hole so the balloon could not be verified to have any ruptures.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that balloon pinhole occurred.The 95% stenosed, 6mm target lesion was located in the moderately tortuous and severely calcified superficial femoral artery.Pre-inflation was performed with a 3mm balloon.After the non-boston scientific guidewire was crossed to the lesion, a 5.0mmx220mmx150cm (4f) sterling balloon catheter was advanced for dilatation.However, during the first inflation at 10 atmospheres for 30 seconds, the balloon twisted.The device was removed.In an attempt to fix the twisted balloon outside of the patient, the guidewire was advanced in and out of the balloon resulting in the guidewire penetrating through the balloon.The procedure was completed with a different device.There were no patient complications nor injuries reported.

• 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: 13599266
• Report Number: 2134265-2022-02030
• Device Sequence Number: 1956382
• Product Code: LIT
• UDI-Device Identifier: 08714729859475
• UDI-Public: 08714729859475
• 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
• Report Date (Section B): 04/10/2022

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: 10/10/2024
• Device Model Number: 24690
• Device Catalogue Number: 24690
• Device Lot Number: 0028176826
• 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: 02/07/2022
• Supplement Date Received by Manufacturer: 03/16/2022
• Initial Report FDA Received Date: 02/25/2022
• Supplement Report FDA Received Date: 04/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE USED: CRUISE; GUIDEWIRE USED: CRUISE; INTRODUCER SHEATH USED: DESTINATION 6F; INTRODUCER SHEATH USED: DESTINATION 6F
• Patient Sex: Unknown