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

Catalog Number	300-015-004
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It has been reported by the physician that the balloon ruptured/burst after 5 seconds, at inflation pressure 30-35 atm (with no nodular calcium).Lesion description and location: lad prox.Stenosis 90%.It was confirmed that the patient was not harmed in any way.Additional information has been requested.
Additional Manufacturer Narrative
The dhr review has been perfomed and no other complaints with the same lot and the same failure mode have been reported.Device has been requested for investigation.Further investigation will be conducted once the device is returned.Complaint has been registered under com (b)(4).
Additional Manufacturer Narrative
This is a follow-up report being submitted to report the results of evaluation of the subject device that was not yet available to the manufacturer when the initial report was made.Specifically, further evaluation efforts have been completed in the form of device evaluation whereby a visual inspection identified a longitudinal balloon burst.With the information provided, the source of the balloon burst cannot be determined.No further anomalies were detected.Risk analysis was performed for the reported event whereby the firm concluded that the observed severity of harm and probability of harm are in alignment with the risk already predicted in the subject device's existing risk analysis.Moreover, the observed risk is within the risk acceptance criteria previously defined in the subject device's risk managemen plan.Accordingly, no corresponding correction or corrective action appear to be necessary at this time.The firm will monitor for additional occurences of this event type and will reconsider the need for corresponding correction or corrective action in due course as appropriate.

• 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: tanja honold ; hungerbüelstrasse 12a; frauenfeld, 8500 ; SZ 8500
• MDR Report Key: 21073401
• Report Number: 3013634084-2025-00001
• Device Sequence Number: 20929280
• Product Code: LOX
• UDI-Device Identifier: 07640142570578
• UDI-Public: (01)07640142570578(10)214781(17)280401
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 300-015-004
• Device Lot Number: 214781
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/03/2025
• Supplement Report FDA Received Date: 03/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2024
• 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