MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION STERLING; CATHETER, PERCUTANEOUS

Model Number	24700
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 70% stenosed target lesion was located in the moderately tortuous and severely calcified right common iliac and superficial femoral arteries.A 5.0mmx40mmx135cm (4f) sterling balloon catheter was advanced for dilatation.However, during the first inflation at 12 atmospheres for 15 seconds, the balloon ruptured.Subsequently, another 6.0mmx60mmx135cm (4f) sterling balloon catheter was advanced but also ruptured on the first inflation at around 12 atmospheres for 15 seconds.Both devices were removed over the wire and the procedure was completed with a different device.There were no patient complications reported.
Event or Problem Description
It was reported that balloon rupture occurred.The 70% stenosed target lesion was located in the moderately tortuous and severely calcified right common iliac and superficial femoral arteries.A 5.0mmx40mmx135cm (4f) sterling balloon catheter was advanced for dilatation.However, during the first inflation at 12 atmospheres for 15 seconds, the balloon ruptured.Subsequently, another 6.0mmx60mmx135cm (4f) sterling balloon catheter was advanced but also ruptured on the first inflation at around 12 atmospheres for 15 seconds.Both devices were removed over the wire and the procedure was completed with a different device.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.Sterling balloon catheter was returned for analysis.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed no damages.Microscopic examination revealed a pinhole in the balloon from the tip.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed there is a pinhole in the balloon.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18069611
• Report Number: 2124215-2023-59124
• Device Sequence Number: 15395873
• Product Code: DQY
• UDI-Device Identifier: 08714729122906
• UDI-Public: 08714729122906
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K053116
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2023

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: 09/25/2026
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0032509520
• 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: 10/19/2023
• Supplement Date Received by Manufacturer: 11/14/2023
• Initial Report FDA Received Date: 11/03/2023
• Supplement Report FDA Received Date: 11/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2023
• 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