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

Model Number	24703
Medical Device Problem Codes	Break (1069); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the catheter shaft broke.A sterling sl 3.00mm x 150mm, 90cm balloon catheter was selected for use to treat peripheral arterial disease of the superficial femoral artery, where it was noted that the stenosed target lesion was very calcified.Another manufacturer 0.035-inch guidewire could not pass, but the 0.018-inch was able to pass through the stenosis.The catheter was advanced to the lesion, however during dilation the calcification was so strong that the balloon was damaged and was knocked down.The physician removed the balloon, but the second part of the sterling remained inside and was able to be fully removed along with the guidewire.Another sterling sl 3.00mm x 150mm, 90cm balloon catheter was used to dilate the lesion a bit, and a smaller sized sterling balloon catheter was chosen, however, was not compatible with the guidewire.Post- dilation the larger 0.035-inch guidewire was able to pass, and an athletics was chosen to complete the procedure without sequela.
Additional Manufacturer Narrative
(b)(6).
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6).Device eval by manufacturer: 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 that the balloon was separated 39mm from the tip, and the guidewire lumen was also separated 20.3cm from the tip.Microscopic examination revealed no additional damages.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed separation of the balloon and guidewire lumen.
Event or Problem Description
It was reported that the catheter shaft broke.A sterling sl 3.00mm x 150mm, 90cm balloon catheter was selected for use to treat peripheral arterial disease of the superficial femoral artery, where it was noted that the stenosed target lesion was very calcified.Another manufacturer 0.035-inch guidewire could not pass, but the 0.018-inch was able to pass through the stenosis.The catheter was advanced to the lesion, however during dilation the calcification was so strong that the balloon was damaged and was knocked down.The physician removed the balloon, but the second part of the sterling remained inside and was able to be fully removed along with the guidewire.Another sterling sl 3.00mm x 150mm, 90cm balloon catheter was used to dilate the lesion a bit, and a smaller sized sterling balloon catheter was chosen, however, was not compatible with the guidewire.Post- dilation the larger 0.035-inch guidewire was able to pass, and an athletis was chosen to complete the procedure without sequela.

• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15772753
• Report Number: 2124215-2022-45963
• Device Sequence Number: 16919360
• Product Code: DQY
• UDI-Device Identifier: 08714729782490
• UDI-Public: 08714729782490
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2022

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: 06/01/2024
• Device Model Number: 24703
• Device Catalogue Number: 24703
• Device Lot Number: 0029515728
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/26/2022
• Supplement Date Received by Manufacturer: 12/07/2022
• Initial Report FDA Received Date: 11/10/2022
• Supplement Report FDA Received Date: 12/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/02/2022
• 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
• Patient Sex: Unknown