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

Model Number	24700
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 95% stenosed target lesion was located in a shunt in the moderately tortuous and moderately calcified vessel.A 6.0mmx20mmx40cm (4f) sterling balloon catheter was advanced for dilatation.However, during the initial inflation at 14 atmospheres for 30 seconds, the balloon ruptured.The device was removed and the procedure was completed with another of the same device.There were no complications nor injuries reported and the patient was in good condition.
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The 95% stenosed target lesion was located in a shunt in the moderately tortuous and moderately calcified vessel.A 6.0mmx20mmx40cm (4f) sterling balloon catheter was advanced for dilatation.However, during the initial inflation at 14 atmospheres for 30 seconds, the balloon ruptured.The device was removed and the procedure was completed with another of the same device.There were no complications nor injuries reported and the patient was in good condition.
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 longitudinal tear in the balloon 3mm from the tip and is approximately 18mm long.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed there is a longitudinal tear in the balloon.

• 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: 13509617
• Report Number: 2134265-2022-01465
• Device Sequence Number: 19843464
• Product Code: DQY
• UDI-Device Identifier: 08714729123743
• UDI-Public: 08714729123743
• 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): 03/28/2022

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: 04/23/2023
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0025464517
• 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: 02/04/2022
• Supplement Date Received by Manufacturer: 03/11/2022
• Initial Report FDA Received Date: 02/10/2022
• Supplement Report FDA Received Date: 03/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2020
• 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 Sex: Unknown