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

Catalog Number	300-015-004
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The following event was reported.The opn nc would not deliver through a concentric highly calcified lcx lesion in several attempts.The physician reported that catheter friction was felt during insertion and the shaft broke proximally.The event did not affect the patient, who was discharged home after the intervention.
Additional Manufacturer Narrative
During a retrospective quality improvement effort this complaint was assessed as reportable.A corrective and preventive action has been initiated to address the reportability of complaints.The physician tried to insert the opn nc across a concentric highly calcified lcx lesion.The product would not deliver and the proximal shaft broke.After prepping the lesion with multiple catheters (compliant, cutting and nc), the lesion was finally treated with another opn nc.Excessive force may have been applied when trying to proceed through a highly calcified lesion, causing the device to buckle and ultimately break.The instructions for use state in the precautions and directions for use sections: "if resistance during insertion is encountered do not use force to advance the ptca dilatation catheter as this may result in damage to the ptca dilatation catheter.Stop the procedure and determine the cause." a review of the lot history record identified no manufacturing non-conformities issued to the reported device or lot specific quality issues.Analysis of this complaint failure mode showed that the severity and frequency of this failure mode is within the current approved risk acceptance criteria.The event did not affect the patient, who was discharged home after the intervention.

• Brand Name: OPN NC
• 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: erhard huesler ; hungerbüelstrasse 12a; frauenfeld, 8500 ; SZ 8500
• MDR Report Key: 18196188
• Report Number: 3013634084-2023-00002
• Device Sequence Number: 12400467
• Product Code: LOX
• UDI-Device Identifier: 07640142570578
• UDI-Public: (01)07640142570578(10)207367(17)260518
• Combination Product (Y/N): N
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/21/2023

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 Catalogue Number: 300-015-004
• Device Lot Number: 207367
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2023
• Initial Report FDA Received Date: 11/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDELINER; OTHER COMPLIANT, CUTTING NC CATHETERS; OTHER OPN NC
• Patient Sex: Prefer Not To Disclose