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

Model Number	24702
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	04/23/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that balloon detachment occurred.The target lesion was located in the left external iliac artery.A 3.0 mm x 100 mm x 150 cm sterling sl balloon catheter was advanced for dilatation.However, the balloon sheared in the patient's iliac artery.Subsequently, the detached portion of the balloon was trapped with a bare-metal stent against the vessel wall.The procedure was completed with a different device.No further complications were reported and the patient was uninjured.
Additional Manufacturer Narrative
Updated describe event or problem.Device evaluated by mfr.: the device as returned for analysis.The device was bloody, and part of the balloon and the whole tip was missing.The balloon was loosely folded.The balloon, proximal weld, inner/outer shaft were microscopically and visually inspected.Inspection revealed 37mm of the balloon were returned with the separated end jagged.Inspection of the rest of the device found no other damage or defect.The reported balloon detachment was confirmed.
Event or Problem Description
It was reported that balloon detachment occurred.The target lesion was located in the left external iliac artery.A 3.0mmx100mmx150cm sterling sl balloon catheter was advanced for dilatation.However, the balloon sheared in the patient's iliac artery.Subsequently, the detached portion of the balloon was trapped with a bare-metal stent against the vessel wall.The procedure was completed with a different device.No further complications were reported and the patient was uninjured.It was further reported that the 90% stenosed, 200mm target lesion was located in a not very tortuous and heavily severely calcified at the origin of superficial femoral artery.

• 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: 8616758
• Report Number: 2134265-2019-05127
• Device Sequence Number: 19335451
• Product Code: DQY
• UDI-Device Identifier: 08714729782292
• UDI-Public: 08714729782292
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K093720
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2019

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: 02/12/2020
• Device Model Number: 24702
• Device Catalogue Number: 24702
• Device Lot Number: 0021734451
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2019
• Initial Date Received by Manufacturer: 04/23/2019
• Supplement Date Received by Manufacturer: 05/22/2019
• Initial Report FDA Received Date: 05/16/2019
• Supplement Report FDA Received Date: 06/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR