MAUDE Adverse Event Report: SIS Medical AG OPN NC 3.0 x 15 PTCA Dilatation Catheter; Catheter, Transluminal Coronary Angioplasty, Percutaneous (PTCA Catheter)

Model Number	OPN NC
Medical Device Problem Codes	Break (1069); Stretched (1601); Improper or Incorrect Procedure or Method (2017); Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Sis medical ag reference number:(b)(4).Investigation outcome: a comprehensive review of the device history records for the affected batch confirmed that the product met all specified requirements at the time of release.No manufacturing or release anomalies related to the reported event were identified.The returned device and accessories were visually inspected.Blood residue was present along the catheter.The complaint device showed elongation and breakage of the outer shaft, and the balloon was located inside the guiding catheter.Kinks were observed along the hypotube.In addition, two guide wires were returned.According to the information received, the event occurred during the procedure on (b)(6)2026.The reporter stated that the balloon failed to collapse after dilatation and subsequently tore off.The initial information received on (b)(6)2026 stated: "balloon abgerissen, da sich balloon nicht zusammengefaltet hat nach dilatation" ("balloon torn off as it failed to collapse following dilatation").The reporter indicated that no guide wire friction was encountered during insertion.It was reported that the balloon had been inflated to 40 atm, then the shaft broke and the balloon could not be deflated.During retrieval, the outer shaft reportedly tore or ruptured.The reporter further stated that the balloon tore because it did not contract after dilatation.The instructions for use require the balloon to be fully deflated before removal, prohibit forceful retraction when resistance is encountered, and state that balloon pressure must not exceed the rated burst pressure indicated on the package label.The applicable instructions and warnings are reproduced below: catheter removal 13.After dilation, fully deflate the balloon and confirm that the balloon is fully deflated.Apply negative pressure until the balloon is fully deflated as observed under fluoroscopy.14.Loosen the hemostatic valve on the guiding catheter.Hold the guide wire position and withdraw the ptca dilatation catheter into the guiding catheter.Remove the ptca dilatation catheter from the system.Precaution: if resistance is encountered during removal do not use force to retract the device as this may result in damage to the ptca dilatation catheter.Simultaneous removal of the entire system (e.G.Ptca dilatation catheter, guide wire and guiding catheter) might be advised.Warning · do not advance or retract the ptca dilatation catheter if unusual resistance is felt.When excessive force needs to be applied to move the ptca dilatation catheter, stop the procedure before proceeding.Determine the root cause of the resistance before moving the catheter.Advancement by force may results in damage to the vessel and/or the ptca dilatation catheter.This may necessitate recovery of fragments.· do not advance or retract the ptca dilatation catheter unless it is fully deflated.· balloon pressure should not exceed the rated burst pressure (rbp) indicated on the package label for each balloon.The rbp is based on the results of in vitro testing.Use of a pressure monitoring device is recommended to prevent over-pressurization.If inflated above the rated burst pressure, there is a risk of catheter burst.Based on the information received, the device history review, and the physical inspection findings, the most probable root cause was use-related.The reported balloon inflation pressure of 40 atm exceeded the rated burst pressure specified on the package label.Subsequent retrieval of the device while the balloon was not fully deflated, together with the application of high retrieval forces, most likely caused the observed elongation and breakage of the outer shaft.The device history review identified no manufacturing or release non-conformity related to the event.

• Brand Name: OPN NC 3.0 x 15 PTCA Dilatation Catheter
• Common Device Name: Catheter, Transluminal Coronary Angioplasty, Percutaneous (PTCA Catheter)
• Manufacturer (Section D): SIS Medical AG; hungerbüelstrasse 12a; frauenfeld, 8500 ; SZ 8500
• Manufacturer Contact: florus lowag ; hungerbüelstrasse 12a; frauenfeld, 8500
• MDR Report Key: 50153564
• Report Number: 3013634084-2026-00005
• Device Sequence Number: 13096782
• Product Code: LOX
• UDI-Device Identifier: 07640142570578
• UDI-Public: (01)07640142570578(10)221356(17)291008
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K212393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2026

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: 300-015-004
• Device Lot Number: 221356
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2026
• Supplement Date Received by Manufacturer: 09/17/2026
• Initial Report FDA Received Date: 08/06/2026
• Supplement Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/08/2026
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown