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

Model Number	24703
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that shaft break and removal difficulties occurred.The patient presented with peripheral vascular disease (pvd).The 99% stenosed target lesion was located in moderately tortuous and severely calcified bend of the anterior tibial artery.A 3.0mm x 150mm x 150cm sterling sl balloon catheter was advanced for dilatation and inflation was performed.However, removal difficulties were encountered and the shaft of the balloon sheared off in two pieces over the wire.A snare was advanced then and the sheared portion was retrieved with no complications.The procedure was completed with different device.No patient complications were reported and the patient status was fine.
Event or Problem Description
It was reported that shaft break and removal difficulties occurred.The patient presented with peripheral vascular disease (pvd).The 99% stenosed target lesion was located in moderately tortuous and severely calcified bend of the anterior tibial artery.A 3.0mm x 150mm x 150cm sterling sl balloon catheter was advanced for dilatation and inflation was performed.However, removal difficulties were encountered and the shaft of the balloon sheared off in two pieces over the wire.A snare was advanced then and the sheared portion was retrieved with no complications.The procedure was completed with different device.No patient complications were reported and the patient status was fine.
Additional Manufacturer Narrative
The sterling sl was returned to boston scientific for analysis.The device was inspected for any damage or irregularities.The batch/lot number is a match to the complaint device.The catheter was measured at 56.8 cm long, the distal tip was missing and not returned.The balloon had a rupture of the balloon 60.4 mm from the distal end.A piece of what appears to be the inner tube was separated and measured 21.4 cm long.The complaint was confirmed.

• 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: 14229393
• Report Number: 2134265-2022-04282
• Device Sequence Number: 19904661
• Product Code: DQY
• UDI-Device Identifier: 08714729782315
• UDI-Public: 08714729782315
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/20/2023
• Device Model Number: 24703
• Device Catalogue Number: 24703
• Device Lot Number: 0026968685
• 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: 04/07/2022
• Supplement Date Received by Manufacturer: 05/31/2022
• Initial Report FDA Received Date: 04/27/2022
• Supplement Report FDA Received Date: 06/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 84 YR
• Patient Sex: Male
• Patient Weight: 147 KG
• Patient Race: Black Or African American