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

Model Number	24702
Medical Device Problem Codes	Material Puncture/Hole (1504); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the guidewire perforated the catheter shaft.A 2.0mm x 100mm x 150cm sterling sl balloon catheter was selected for percutaneous transluminal angioplasty (pta).The 99% stenosed, severely calcified and severely tortuous lesion was located in an artery below the knee (btk).There was difficulty advancing the balloon through the lesion.The balloon was removed to exchange for a lower profile balloon.During removal, they observed the non-boston scientific guidewire was protruding through the shaft proximal to the balloon.The procedure was completed with another device.There were no patient complications.
Additional Manufacturer Narrative
Device eval by mfr: the returned product consisted of a sterling sl balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed multiple kinks along the shaft.Microscopic examination revealed a hole in the guidewire lumen and inflation lumen 34mm from the tip.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that the guidewire perforated the catheter shaft.A 2.0mm x 100mm x 150cm sterling sl balloon catheter was selected for percutaneous transluminal angioplasty (pta).The 99% stenosed, severely calcified and severely tortuous lesion was located in an artery below the knee (btk).There was difficulty advancing the balloon through the lesion.The balloon was removed to exchange for a lower profile balloon.During removal, they observed the non-boston scientific guidewire was protruding through the shaft proximal to the balloon.The procedure was completed with another device.There were no patient complications.

• 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: 12774873
• Report Number: 2134265-2021-14009
• Device Sequence Number: 5657724
• Product Code: DQY
• UDI-Device Identifier: 08714729782216
• UDI-Public: 08714729782216
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2021

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: 01/28/2023
• Device Model Number: 24702
• Device Catalogue Number: 24702
• Device Lot Number: 0026710062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/26/2021
• Supplement Date Received by Manufacturer: 12/08/2021
• Initial Report FDA Received Date: 11/08/2021
• Supplement Report FDA Received Date: 12/27/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown