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

Model Number 24700

Device Problems Entrapment of Device (1212); Material Puncture/Hole (1504)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/13/2023

Event Type  malfunction  

Event 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 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.

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 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
• Type of Device: 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
• MDR Text Key: 332278755
• Report Number: 2124215-2023-72778
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K053116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 01/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 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