MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION STERLING SL; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	24703
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.
Event or Problem Description
It was reported that balloon rupture occurred.The 70% stenosed target lesion was located in a shunt in a non-tortuous and moderately calcified vessel.A 4.0mm x 120mm x 150cm sterling sl balloon catheter was advanced for dilatation.However, during initial inflation at nominal burst pressure, the balloon ruptured.The device was pulled slowly and carefully from the patient.The procedure was completed with another of same device.No patient complications were reported and the patient status was stable.
Additional Manufacturer Narrative
A2: age at time of event: 18 years or older device evaluated by mfr.: returned product consisted of a sterling sl balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual and microscopic examination revealed no damages.The device was functionally tested by inflating it to rated burst pressure and it was able to hold pressure.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis could not confirm the reported rupture.
Event or Problem Description
It was reported that balloon rupture occurred.The 70% stenosed target lesion was located in a shunt in a non-tortuous and moderately calcified vessel.A 4.0mm x 120mm x 150cm sterling sl balloon catheter was advanced for dilatation.However, during initial inflation at nominal burst pressure, the balloon ruptured.The device was pulled slowly and carefully from the patient.The procedure was completed with another of same device.No patient complications were reported and the patient status was stable.

• Brand Name: STERLING SL
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• 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: 14436964
• Report Number: 2134265-2022-05677
• Device Sequence Number: 5646095
• Product Code: DQY
• UDI-Device Identifier: 08714729782377
• UDI-Public: 08714729782377
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K093720
• 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): 06/15/2022

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: 01/26/2023
• Device Model Number: 24703
• Device Catalogue Number: 24703
• Device Lot Number: 0026695577
• 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: 05/11/2022
• Supplement Date Received by Manufacturer: 06/10/2022
• Initial Report FDA Received Date: 05/19/2022
• Supplement Report FDA Received Date: 06/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2021
• 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