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

Model Number	24700
Medical Device Problem Codes	Entrapment of Device (1212); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloon got stuck to the guidewire and there was a small hole on balloon shaft.The 95% stenosed target lesion was located in the moderately tortuous and severely calcified iliac artery.A 6.0mmx60mmx80cm (4f) sterling balloon catheter was selected for use.During the procedure, the physician loaded the balloon onto the guidewire, but the balloon got stuck to the wire.The balloon and guidewire were removed together and upon checking, a small hole in the balloon shaft was noted.The procedure was completed with a non-boston scientific balloon catheter.No patient complications nor injuries were reported.
Event or Problem Description
It was reported that the balloon got stuck to the guidewire and there was a small hole on balloon shaft.The 95% stenosed target lesion was located in the moderately tortuous and severely calcified iliac artery.A 6.0mmx60mmx80cm (4f) sterling balloon catheter was selected for use.During the procedure, the physician loaded the balloon onto the guidewire, but the balloon got stuck to the wire.The balloon and guidewire were removed together and upon checking, a small hole in the balloon shaft was noted.The procedure was completed with a non-boston scientific balloon catheter.No patient complications nor injuries were reported.It was further reported that the balloon got stuck to a 018 300 cm boston scientific platinum plus guidewire.Furthermore, the balloon and guidewire have to be removed as one unit, but the guidewire was not able to be removed from the balloon outside the patient.
Additional Manufacturer Narrative
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 stretching to the inflation lumen 5.1cm from the hub.There are multiple buckling to the guidewire lumen.The guidewire lumen is separated from the hub.Microscopic examination revealed no additional damages.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed the froze on wire.
Event or Problem Description
It was reported that the balloon got stuck to the guidewire and there was a small hole on balloon shaft.The 95% stenosed target lesion was located in the moderately tortuous and severely calcified iliac artery.A 6.0mmx60mmx80cm (4f) sterling balloon catheter was selected for use.During the procedure, the physician loaded the balloon onto the guidewire, but the balloon got stuck to the wire.The balloon and guidewire were removed together and upon checking, a small hole in the balloon shaft was noted.The procedure was completed with a non-boston scientific balloon catheter.No patient complications nor injuries were reported.It was further reported that the balloon got stuck to a 018 300 cm boston scientific platinum plus guidewire.Furthermore, the balloon and guidewire have to be removed as one unit, but the guidewire was not able to be removed from the balloon outside the patient.

• 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: 18453451
• Report Number: 2124215-2023-72778
• Device Sequence Number: 15186272
• Product Code: DQY
• UDI-Device Identifier: 08714729123811
• UDI-Public: 08714729123811
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/08/2024

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: 11/08/2024
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0028359787
• 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: 12/13/2023
• Supplement Date Received by Manufacturer: 12/13/2023; 01/12/2024
• Initial Report FDA Received Date: 01/05/2024
• Supplement Report FDA Received Date: 01/09/2024; 02/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE - 018 300 CM PLATINUM PLUS; GUIDEWIRE - 018 300 CM PLATINUM PLUS; GUIDEWIRE - 018 300 CM PLATINUM PLUS
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 63 KG
• Patient Race: Black Or African American