MAUDE Adverse Event Report: SIS MEDICAL AG OPN NC 3.0X15 PTCA DILATATION CATHETER; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS (PTCA CATHETER)

Model Number	OPN NC
Medical Device Problem Codes	Break (1069); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The reporter states that, "the device was being used in the normal fashion, and the shaft broke during the insertion in the middle of the shaft.The other half was retrieved and the parts trashed.There were no kinks observed prior to use.There was no impact to the patient when the broken shaft.They used another modality to finish the procedure.".
Additional Manufacturer Narrative
A review of the dhr has been performed and the lot is within specifications.
Additional Manufacturer Narrative
Subsequent to submission of manufacturer report # 3013634084-2025-00004, the fda received medsun report #(b)(4) through fda's medsun program and forwarded that medsun report to the manufacturer.Sis medical determined that the medsun report was for the same event identified in # 3013634084-2025-00004.The medsun reporter cited the same device name, model number, lot number, udi-di portion, event month, device expiration month, and type of reportable event that were cited by the manufacturer in its initial report.In addition, the event details were similar.The medsun reporter selected "other serious or important medical events" in medsun block b.The medsun reporter states that a balloon was inserted over the wire during a coronary intervention, and that the portion of the balloon shaft that was outside the patient's body broke, and that the balloon was removed and not used, and that all portions of the balloon were accounted for, and that the original intended procedure was a cath lab procedure, and that the problem the user had is "device malfunction - that is, the device did not do what it was supposed to do;", and that the device is available for evaluation.The medsun report identifies the medsun initial reporter along with a user facility, which align with the original report.The medsun report identifies the manufacturer's address as an annapolis, md, usa site that is the address of sis medical ag's regulatory correspondent.Further investigation indicates that the device involved in this incident was discarded and is not available for evaluation.
Additional Manufacturer Narrative
Additional information was received and taken into consideration.No further technical investigation was yet possible, as the distributor reported that the product wasn't yet available for return, and that no pictures are available.With the information provided it is not yet possible to determine what caused the breakage of the shaft during the initial insertion, though it is the manufacturer's understanding that a breakage of the shaft could occur only when high forces are applied, and usually during retraction of the catheter.However, the labeling was nonetheless reviewed to determine if the complaint resulted from inadequacies in the product labelling or a failure by the user to adhere to the labelling, but no such cause nor other anomalies were identified thereby indicating that all of the labeling information appears to meet requirements and specifications.Moreover, the instructions for use (see iu001685-0006 'insertion technique point 10' and 'catheter removal point 14') already includes precautionary statements explaining how shaft damage can occur during insertion and removal.Further to the initial report stating that another modality was used to finish the procedure, it was also reported that said alternative modality was not the opn subject device, and that all opn devices with the same lot numbers were pulled and are being returned to the distributor to be traded for a different lot number.It was also further reported that the other half of the broken shaft was retrieved from the patient.

• Brand Name: OPN NC 3.0X15 PTCA DILATATION CATHETER
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS (PTCA CATHETER)
• Manufacturer (Section D): SIS MEDICAL AG; hungerbüelstrasse 12a; frauenfeld, 8500 ; SZ 8500
• Manufacturer (Section G): SIS MEDICAL AG; hungerbüelstrasse 12a; frauenfeld, 8500 ; SZ 8500
• Manufacturer Contact: florus lowag ; hungerbüelstrasse 12a; frauenfeld, 8500 ; SZ 8500
• MDR Report Key: 23394025
• Report Number: 3013634084-2025-00004
• Device Sequence Number: 15944979
• Product Code: LOX
• UDI-Device Identifier: 07640142570608
• UDI-Public: (01)07640142570608(10)216954(17)281009
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K212393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/12/2026

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 Model Number: OPN NC
• Device Catalogue Number: 350-015-004
• Device Lot Number: 216954
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 10/27/2025
• Supplement Report FDA Received Date: 11/27/2025; 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/09/2025
• 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
• Patient Sex: Unknown