MAUDE Adverse Event Report: SIS MEDICAL AG OPN NC 3.0X10 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	Cardiac Arrest (1762)
Date of Event	02/02/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
During a retrospective quality improvement effort related to an mdsap audit finding, this complaint was assessed as reportable.Corresponding corrective and preventive action has been initiated for improvement of the firm's adverse event reporting process.The device involved in this event was not available for investigation as it was discarded by the clinic.The device history records for this lot of product were reviewed, and no anomalies were noted.In addition, a review of prior complaints does not show any reports with the same lot and same failure mode.The results of the technical investigation and the review of the available information do not reveal any underlying issues that would indicate the need for further corrective or preventive measures.
Event or Problem Description
Treatment of mid lad (left anterior descending coronary artery) in-stent restenosis with minor stent under expansion.Stenosis degree of 40%.Balloon rupture/burst after 2-4 seconds of inflation, at inflation pressure 25 atm.Cardiologist suspected the opn balloon burst upon inflation and was the probable cause of the mechanism for rupture of lad.Balloon was reported to have suddenly lost pressure at 25 atm during inflation.Opn balloon was deflated with blood staining noted in the fluid of the inflation device, which is inconsistent with balloon rupture.Evidence of artery rupture noted angiographically.Cardiac arrest followed.Lad rupture treated with papyrus covered stent, tamponade was drained and the patient successfully rescusistated and transfered to icu.

• Brand Name: OPN NC 3.0X10 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: 21615285
• Report Number: 3013634084-2025-00002
• Device Sequence Number: 20724174
• Product Code: LOX
• UDI-Device Identifier: 07640142570561
• UDI-Public: (01)07640142570561(10)208995(17)261014
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K212393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/15/2025

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 Model Number: OPN NC
• Device Catalogue Number: 300-010-004
• Device Lot Number: 208995
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2024
• Initial Report FDA Received Date: 03/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/14/2023
• 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 Age: 48 YR
• Patient Sex: Male