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 Consequences Or Impact To Patient (2199)
Date of Event	08/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Sex: patient's gender was unclear since both (male/female) were provided.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the intero tibeal artery.After a v18 guidewire passed through, a 3.0mm x 100mm x 150cm sterling sl balloon catheter was advanced for dilatation.However, during inflation at 12 atmospheres the balloon ruptured.The device was removed and the procedure was completed with another of the same device.There were no complications reported and the patient's status was stable.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the intero tibeal artery.After a v18 guidewire passed through, a 3.0mm x 100mm x 150cm sterling sl balloon catheter was advanced for dilatation.However, during inflation at 12 atmospheres the balloon ruptured.The device was removed and the procedure was completed with another of the same device.There were no complications reported and the patient's status was stable.It was further reported that the lesion was 40-50% stenosed, non- tortuous and moderately calcified.The balloon ruptured during the first inflation.
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of a sterling sl balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There were numerous kinks.There was contrast and blood in the inflation lumen and balloon, and blood in the guidewire lumen.The balloon was loosely folded.Microscopic inspection revealed tip damage.The device was prepped with an inflation device filled with water and connected to the inflation port to inflate the device.There was a pinhole 15mm proximal of the distal marker band.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the intero tibeal artery.After a v18 guidewire passed through, a 3.0mm x 100mm x 150cm sterling sl balloon catheter was advanced for dilatation.However, during inflation at 12 atmospheres the balloon ruptured.The device was removed and the procedure was completed with another of the same device.There were no complications reported and the patient's status was stable.It was further reported that the lesion was 40-50% stenosed, non- tortuous and moderately calcified.The balloon ruptured during the first inflation.

• 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: 10443979
• Report Number: 2134265-2020-11553
• Device Sequence Number: 16826030
• Product Code: DQY
• UDI-Device Identifier: 08714729782292
• UDI-Public: 08714729782292
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• PMA/510(K) Number: K093720
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/28/2020

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: 10/21/2020
• Device Model Number: 24702
• Device Catalogue Number: 24702
• Device Lot Number: 0022828381
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2020
• Initial Date Received by Manufacturer: 08/19/2020
• Supplement Date Received by Manufacturer: 08/26/2020; 10/14/2020
• Initial Report FDA Received Date: 08/24/2020
• Supplement Report FDA Received Date: 09/02/2020; 10/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE: V18.; GUIDEWIRE: V18.; GUIDEWIRE: V18.; GUIDEWIRE: V18
• Patient Age: 60 YR
• Patient Weight: 85