MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION THREADER?; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number	H7493926912120
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E1 initial reporter address 1: (b)(6).E1 initial reporter phone: (b)(6).
Event or Problem Description
It was reported that the catheter could not be withdrawn, fractured and remained inside patient.The patient presented with chronic total occlusion (cto) and underwent coronary percutaneous coronary intervention stent implantation.The 100% stenosed target lesion was located in the moderately calcified left anterior descending (lad) artery.After the cto was successfully opened in the lad, it was found that the opening of the septal branch was severely stenosed.The 1.2mm x 12mm fg threader micro dilation balloon catheter was used to pre-dilate the septal branch.After the balloon was dilated with a pressure pump, it was found that it could not be withdrawn or advanced forward and pulled backward.The physician then cut the delivery shaft and advanced a guidezilla to remove it.After multiple attempts to remove the device, the tip of the catheter was fractured.An attempt was made to grasp the device fragment but failed, and a stent was immediately implanted to cover the fractured tip.The procedure was completed.No complications were reported, and the patient was stable post procedure.
Event or Problem Description
It was reported that the catheter could not be withdrawn, fractured and remained inside patient.The patient presented with chronic total occlusion (cto) and underwent coronary percutaneous coronary intervention stent implantation.The 100% stenosed target lesion was located in the moderately calcified left anterior descending (lad) artery.After the cto was successfully opened in the lad, it was found that the opening of the septal branch was severely stenosed.The 1.2mm x 12mm fg threader micro dilation balloon catheter was used to pre-dilate the septal branch.After the balloon was dilated with a pressure pump, it was found that it could not be withdrawn or advanced forward and pulled backward.The physician then cut the delivery shaft and advanced a guidezilla to remove it.After multiple attempts to remove the device, the tip of the catheter was fractured.An attempt was made to grasp the device fragment but failed, and a stent was immediately implanted to cover the fractured tip.The procedure was completed.No complications were reported, and the patient was stable post procedure.It was further reported that the threader catheter was used for opening the blood vessel during the cto procedure and was not used for pre-dilation.A pre-dilation balloon was used before.The physician noted that there was stenosis at the orifice of the septal branch during the opening process, so this threader was placed at the opening of the septal branch.
Additional Manufacturer Narrative
E1 initial reporter address 1: (b)(6).E1 initial reporter phone: (b)(6).Device evaluated by manufacturer: the device was returned in a broken condition with the distal section including the balloon and tip not returned.Visual and tactile inspection revealed multiple hypotube kinks along the length of the hypotube shaft.Two shaft breaks were identified.One break was noted in the proximal hypotube (2mm distal from the distal end of the strain relief).The second break was noted in the more distal powercoil section of the shaft.The section of the device distal of this second break site, including distal polymer shaft, balloon and tip was not returned.

• Brand Name: THREADER?
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, 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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 22171190
• Report Number: 2124215-2025-33993
• Device Sequence Number: 15832695
• Product Code: LOX
• UDI-Device Identifier: 08714729848127
• UDI-Public: (01)08714729848127(17)270108(10)35579373
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K134031
• 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
• Report Date (Section B): 07/30/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: H7493926912120
• Device Catalogue Number: H7493926912120
• Device Lot Number: 0035579373
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2025
• Supplement Date Received by Manufacturer: 07/04/2025
• Initial Report FDA Received Date: 06/09/2025
• Supplement Report FDA Received Date: 07/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 60 KG