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 Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2025
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 complainant stated that he opn balloon broke when it reached 22 atmospheres for approximately 15 seconds even though it is manufactured to withstand 34 atmospheres.The complainant reports that the patient didn't' have a stent, that the event did not affect the patient, and that the stent was eventually successfully placed.
Additional Manufacturer Narrative
A comprehensive review of the device history record (dhr) confirmed that the subject lot was manufactured, processed, and tested in accordance with approved specifications.The product involved in the complaint was returned for investigation on 23.Jan.2026.A visual inspection was performed on the returned device and during the investigation the alleged balloon burst was confirmed.Several kinks were observed in the hypotube.The complaint form was received and the information reported, including any additional information provided, was taken into consideration for the technical investigation.It was reported that the balloon ruptured while being inflated at approx.22 atm after approx.15 seconds during the procedure.A 100% visual inspection of the final product was performed and product ref.300-015-004 lot 218313 fulfilled all specifications at the time of batch release.At this time, it remains unclear whether the patient had significant stenosis, calcified plaque, or other lesion characteristics that may have increased resistance to balloon expansion and contributed to the reported rupture at 22 atm.Additionally, balloon damage cannot be excluded during device preparation or handling prior to insertion.Complaints for the last 3 years were reviewed, and there is no indication of a lot specific issue.Based on the available information and visual inspection, the exact root cause cannot be determined.The reported balloon rupture is possibly related to circumstances of the procedure.As there was no leak noted during preparation, this does not suggest a product quality issue.

• 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: 23930997
• Report Number: 3013634084-2025-00005
• Device Sequence Number: 8909501
• Product Code: LOX
• UDI-Device Identifier: 07640142570608
• UDI-Public: (01)07640142570608(10)218313(17)290218
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 02/27/2025

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: 300-015-004
• Device Lot Number: 218313
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 12/30/2025
• Supplement Report FDA Received Date: 02/26/2026; 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2025
• 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