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

Model Number	H74939032702010
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon tip detachment occurred.The target lesion was located in the mildly tortuous and non-calcified arteriovenous fistula.A 7.0mmx20mmx135cm (4f) sterling balloon catheter was advanced for dilatation.However, during removal, the tip of the balloon was detached.The tip was removed together with the catheter successfully from the patient.The procedure was completed with another sterling balloon.There were no patient complications reported.
Additional Manufacturer Narrative
Updated d4: lot number from 0031131138 to 0030395474.Device evaluated by mfr.: returned product consisted of a sterling balloon catheter with an unknown guidewire stuck inside the distal end of the separated device.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed that the inflation lumen is separated 146.8cm from the hub.The guidewire lumen is separated 138.5cm from the hub.There is buckling to the inflation lumen 142.6cm from the hub.The inflation lumen is stretched 128cm and 138.5cm from the hub.Microscopic examination revealed no additional damages.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that balloon tip detachment occurred.The target lesion was located in the mildly tortuous and non-calcified arteriovenous fistula.A 7.0mmx20mmx135cm (4f) sterling balloon catheter was advanced for dilatation.However, during removal, the tip of the balloon was detached.The tip was removed together with the catheter successfully from the patient.The procedure was completed with another sterling balloon.There were no patient complications reported.
Additional Manufacturer Narrative
Updated d4: lot number from 0031131138 to 0030395474.Device evaluated by mfr.: returned product consisted of a sterling balloon catheter with an unknown guidewire stuck inside the distal end of the separated device.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed that the inflation lumen is separated 146.8cm from the hub.The guidewire lumen is separated 138.5cm from the hub.There is buckling to the inflation lumen 142.6cm from the hub.The inflation lumen is stretched 128cm and 138.5cm from the hub.Microscopic examination revealed no additional damages.Inspection of the remainder of the device presented no other damage or irregularities.This report is being filed to correct the model number and unique identifier (udi) # in response to an fda request.
Event or Problem Description
It was reported that balloon tip detachment occurred.The target lesion was located in the mildly tortuous and non-calcified arteriovenous fistula.A 7.0mmx20mmx135cm (4f) sterling balloon catheter was advanced for dilatation.However, during removal, the tip of the balloon was detached.The tip was removed together with the catheter successfully from the patient.The procedure was completed with another sterling balloon.There were no patient complications reported.

• 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: 18141675
• Report Number: 2124215-2023-64220
• Device Sequence Number: 15100155
• Product Code: DQY
• UDI-Device Identifier: 08714729123996
• UDI-Public: (01)08714729123996(17)251020(10)30395474
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/03/2024

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: 10/20/2025
• Device Model Number: H74939032702010
• Device Catalogue Number: 24700
• Device Lot Number: 0030395474
• 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: 10/25/2023
• Supplement Date Received by Manufacturer: 01/12/2024; 06/12/2024
• Initial Report FDA Received Date: 11/15/2023
• Supplement Report FDA Received Date: 01/29/2024; 07/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2022
• 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