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

Model Number 24702

Device Problems Material Puncture/Hole (1504); Difficult to Advance (2920)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/22/2021

Event Type  malfunction  

Event 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.

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 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
• Type of Device: 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
• MDR Text Key: 280820607
• Report Number: 2134265-2021-14009
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 08714729782216
• UDI-Public: 08714729782216
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K093720
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 12/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/28/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1