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

Model Number	H74939031602010
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3 - date of event: the event date of (b)(6) 2023 is estimated based of the aware date of 04dec2023 as the exact date was not reported.
Event or Problem Description
It was reported that balloon rupture occurred.A 6.0mmx20mmx135cm (4f) sterling balloon was advanced for dilatation.However, the balloon was pierced.No complications reported.
Additional Manufacturer Narrative
B3 - date of event: the event date of 01dec2023 is estimated based of the aware date of 04dec2023 as the exact date was not reported.Device evaluated by mfr: the 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 hole in the guidewire lumen 7mm from the tip.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed there is a hole in the guidewire lumen which would cause the balloon the fail to inflate.
Event or Problem Description
It was reported that balloon rupture occurred.A 6.0mmx20mmx135cm (4f) sterling balloon was advanced for dilatation.However, the balloon was pierced.No complications reported.
Event or Problem Description
It was reported that balloon rupture occurred.A 6.0mmx20mmx135cm (4f) sterling balloon was advanced for dilatation.However, the balloon was pierced.No complications reported.
Additional Manufacturer Narrative
This report is being filed to correct the model number and unique identifier (udi) # in response to an fda request.B3 - date of event: the event date of 01dec2023 is estimated based of the aware date of 04dec2023 as the exact date was not reported.Device evaluated by mfr: the 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 hole in the guidewire lumen 7mm from the tip.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed there is a hole in the guidewire lumen which would cause the balloon the fail to inflate.

• 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: 18369359
• Report Number: 2124215-2023-71830
• Device Sequence Number: 7711205
• Product Code: DQY
• UDI-Device Identifier: 08714729757252
• UDI-Public: (01)08714729757252(17)260412(10)31417854
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K141150
• 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): 07/02/2024

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: 04/12/2026
• Device Model Number: H74939031602010
• Device Catalogue Number: 24690
• Device Lot Number: 0031417854
• 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: 12/04/2023
• Supplement Date Received by Manufacturer: 02/14/2024; 06/12/2024
• Initial Report FDA Received Date: 12/20/2023
• Supplement Report FDA Received Date: 03/06/2024; 07/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/13/2023
• 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