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

Model Number	H74939032604080
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter address 1: (b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The 99% stenosed target lesion was located in a shunt in the moderately tortuous and severely calcified vessel in the left forearm.A 6.0mmx40mmx80cm (4f) sterling balloon catheter was advanced for dilatation.During the initial inflation, the balloon ruptured upon application of pressure.The device was removed, and the procedure was completed with another of same device.There were no complications reported and the patient was in good condition after the procedure.
Additional Manufacturer Narrative
E1 - initial reporter address 1: (b)(6) device evaluated by mfr: the complaint device was received for product 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 11mm 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.
Event or Problem Description
It was reported that balloon rupture occurred.The 99% stenosed target lesion was located in a shunt in the moderately tortuous and severely calcified vessel in the left forearm.A 6.0mmx40mmx80cm (4f) sterling balloon catheter was advanced for dilatation.During the initial inflation, the balloon ruptured upon application of pressure.The device was removed, and the procedure was completed with another of same device.There were no complications reported and the patient was in good condition after the procedure.
Event or Problem Description
It was reported that balloon rupture occurred.The 99% stenosed target lesion was located in a shunt in the moderately tortuous and severely calcified vessel in the left forearm.A 6.0mmx40mmx80cm (4f) sterling balloon catheter was advanced for dilatation.During the initial inflation, the balloon ruptured upon application of pressure.The device was removed, and the procedure was completed with another of same device.There were no complications reported and the patient was in good condition after the procedure.
Additional Manufacturer Narrative
"udi related data quality updates only.This report is being filed as a correction in response to an fda request for the complete the unique identifier (udi) #." e1: initial reporter address 1: (b)(6).Device evaluated by mfr: the complaint device was received for product 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 11mm 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: 18308083
• Report Number: 2124215-2023-70211
• Device Sequence Number: 20371411
• Product Code: DQY
• UDI-Device Identifier: 08714729123798
• UDI-Public: (01)08714729123798(17)20240311(10)0026959468
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/24/2024

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: 03/11/2024
• Device Model Number: H74939032604080
• Device Catalogue Number: 24700
• Device Lot Number: 0026959468
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/07/2023
• Supplement Date Received by Manufacturer: 01/04/2024; 07/09/2024
• Initial Report FDA Received Date: 12/11/2023
• Supplement Report FDA Received Date: 01/05/2024; 07/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2021
• 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
• Patient Sex: Unknown