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

Model Number	24702
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The patient presented with peripheral artery disease (pad).The 90% stenosed target lesion was located in the mildly tortuous and severely calcified superficial femoral artery.A 2mm x 40mm x 145cm coyote es balloon catheter was advanced for dilation.However, during initial inflation at 12 atmospheres for 10 seconds, the balloon ruptured on the middle part.The device was removed.A 2.0mm x 100mm x 90cm sterling sl balloon catheter was advanced for dilatation.The balloon also ruptured during initial inflation at 12 atmospheres for 10 seconds.The device was removed and the procedure was completed with a different device.There were no patient complications nor injuries reported and the patient was in good condition.
Event or Problem Description
It was reported that balloon rupture occurred.The patient presented with peripheral artery disease (pad).The 90% stenosed target lesion was located in the mildly tortuous and severely calcified superficial femoral artery.A 2mm x 40mm x 145cm coyote es balloon catheter was advanced for dilation.However, during initial inflation at 12 atmospheres for 10 seconds, the balloon ruptured on the middle part.The device was removed.A 2.0mm x 100mm x 90cm sterling sl balloon catheter was advanced for dilatation.The balloon also ruptured during initial inflation at 12 atmospheres for 10 seconds.The device was removed and the procedure was completed with a different device.There were no patient complications nor injuries reported and the patient was in good condition.It was further reported that both balloon catheters were inflated twice before they ruptured.

• 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: 14213469
• Report Number: 2134265-2022-04819
• Device Sequence Number: 1803456
• Product Code: DQY
• UDI-Device Identifier: 08714729782391
• UDI-Public: 08714729782391
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 06/01/2022

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: 11/30/2022
• Device Model Number: 24702
• Device Catalogue Number: 24702
• Device Lot Number: 0026435561
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/21/2022
• Supplement Date Received by Manufacturer: 05/25/2022
• Initial Report FDA Received Date: 04/26/2022
• Supplement Report FDA Received Date: 06/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE - COMMAND 300; GUIDEWIRE - COMMAND 300
• Patient Sex: Unknown