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 Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/28/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the severely tortuous and severely calcified superficial femoral artery.A 3.0mm x 100mm x 150cm sterling sl balloon catheter was advanced for dilatation.However, during second inflation under rated burst pressure, the balloon ruptured.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was good.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the severely tortuous and severely calcified superficial femoral artery.A 3.0mm x 100mm x 150cm sterling sl balloon catheter was advanced for dilatation.However, during second inflation under rated burst pressure, the balloon ruptured.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was good.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a sterling sl balloon catheter and part of an introducer sheath.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 48mm from the tip.Inspection of the remainder of the device presented no other damage or irregularities.

• Brand Name: STERLING SL
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11103150
• Report Number: 2134265-2020-18645
• Device Sequence Number: 3774228
• Product Code: DQY
• UDI-Device Identifier: 08714729782292
• UDI-Public: 08714729782292
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2021

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: 12/06/2020
• Device Model Number: 24702
• Device Catalogue Number: 24702
• Device Lot Number: 0023051609
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2021
• Initial Date Received by Manufacturer: 12/28/2020
• Supplement Date Received by Manufacturer: 03/05/2021
• Initial Report FDA Received Date: 12/31/2020
• Supplement Report FDA Received Date: 03/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR