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	04/06/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a balloon rupture occurred.Vascular access was obtained via the left femoral artery.The 30% stenosed, 100mm in length, 4.5mm vessel diameter, eccentric, de novo, target lesion was located in the non-tortuous and moderately calcified lower left limb.The atherectomy was performed with a jetstream 2.1/3 catheter over a 14 thruway guide.A 4.0mm x 120mm x 150cm sterling sl was flushed with a saline using 10ml syringe through the wire conduit and a little water came out of the distal end of catheter.The balloon was then advanced with a thruway guide 14 and inflated with an encore 26 at 6 and 14 atmospheres respectively.However, upon reaching at 10 atmospheres insufflator began to drop rapidly suspected with a balloon rupture.Angiography shows leaking of contrast medium inside balloon into the vessel.The device was then removed without difficulty and the procedure was completed with another of same device.No patient complications were reported and that patient's 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 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 hole in the guidewire lumen 34.5cm from the tip.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that a balloon rupture occurred.Vascular access was obtained via the left femoral artery.The 30% stenosed, 100mm in length, 4.5mm vessel diameter, eccentric, de novo, target lesion was located in the non-tortuous and moderately calcified lower left limb.The atherectomy was performed with a jetstream 2.1/3 catheter over a 14 thruway guide.A 4.0mm x 120mm x 150cm sterling sl was flushed with a saline using 10ml syringe through the wire conduit and a little water came out of the distal end of catheter.The balloon was then advanced with a thruway guide 14 and inflated with an encore 26 at 6 and 14 atmospheres respectively.However, upon reaching at 10 atmospheres insufflator began to drop rapidly suspected with a balloon rupture.Angiography shows leaking of contrast medium inside balloon into the vessel.The device was then removed without difficulty and the procedure was completed with another of same device.No patient complications were reported and that patient's 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
• MDR Report Key: 11755427
• Report Number: 2134265-2021-05209
• Device Sequence Number: 3192555
• Product Code: DQY
• UDI-Device Identifier: 08714729782377
• UDI-Public: 08714729782377
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2021

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: 10/24/2020
• Device Model Number: 24703
• Device Catalogue Number: 24703
• Device Lot Number: 0022846483
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2021
• Initial Date Received by Manufacturer: 04/09/2021
• Supplement Date Received by Manufacturer: 06/16/2021
• Initial Report FDA Received Date: 04/30/2021
• Supplement Report FDA Received Date: 07/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1