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	Material Rupture (1546); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	04/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the dhr has been performed and the lot is within specifications.Further investigation will be conducted once the device is returned.
Event or Problem Description
The clinician reported via a distributor that during delivery the shaft of an opn nc balloon catheter "snapped in half" while advancing into the patient through the guiding catheter.There was no reported impact to the patient and the patient was discharged home.
Additional Manufacturer Narrative
The device involved in this event was not returned for investigation.As previously stated, we have completed a comprehensive review of the device history records for the batch, confirming that the product was within specification at the time of release.In addition, a review of product labelling, including instructions for use, was performed 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 could be confirmed during this review.No further technical investigation was conducted, as the distributor has confirmed that the product was unavailable for return and no pictures are available.Through the distributor, the customer reported that the shaft snapped when advancing through the guide catheter, however the entire device was retrieved and no pieces from the broken shaft were left in the patient.It has been confirmed that the breakage occurred during the initial insertion when the device was inside the guide catheter.The user also stated that it is unknown if the catheter was caught in the stent.With the information provided it is not possible to determine what caused the breakage of the shaft during the initial insertion.A breakage of the shaft could occur only when high forces are applied, and these higher forces usually occur during the retraction of the catheter.Without the product and with the available information it cannot be determined what caused the reported event.

• 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: 22061494
• Report Number: 3013634084-2025-00003
• Device Sequence Number: 20949689
• Product Code: LOX
• UDI-Device Identifier: 07640142570608
• UDI-Public: (01)07640142570608(10)211269(17)270419
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2025

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: 211269
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/21/2025
• Supplement Report FDA Received Date: 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/19/2023
• 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: Male