MAUDE Adverse Event Report: SIS MEDICAL AG OPN NC 3.5X10 PTCA DILATATION CATHETER; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLAST, PERCUTANEOUS (PTCA)

Catalog Number	350-010-004
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The report of this mdr has been delayed by technical reasons when uploading to the electronic submission gateway.In addition, it is sent as part of a corrective action due to an mdsap audit finding.This mdr identifies a device malfunction.The investigation on the returned device has been concluded and the most probable root cause is suspected to be excessive force applied when retracting the device.The ifu states in the precautions and in the directions for use sections: "if resistance is encountered during removal do not used 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." a review of the device history record identified no manufacturing non-conformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history of the reported lot did not indicate a lot specific quality issue.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.
Event or Problem Description
It was reported from the institution that during a percutaneous ventricular assist device removal (pvad) an opn nc balloon was dilated to 28 atm during 4 inflations with the specified product indeflator.Balloon functioned as expected but upon removal from the artery into the guide catheter, the balloon shaft fractured in the guide catheter.Balloon catheter was unable to safely be removed from guide catheter.Decision was made to remove the guide catheter with the fractured opn balloon inside.After removal from patient body, balloon catheter was pulled out of guide catheter and guide catheter was flushed to confirm all parts were accounted for.No foreign body retained.Guidewires (asahi sion blue), balloon, and guide catheter all removed as single unit and replaced with new equipment to complete procedure.Sis medical was informed, that no patient injuries occurred and the patient was discharged home.

• Brand Name: OPN NC 3.5X10 PTCA DILATATION CATHETER
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLAST, PERCUTANEOUS (PTCA)
• 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: 18196128
• Report Number: 3013634084-2023-00001
• Device Sequence Number: 6553534
• Product Code: LOX
• UDI-Device Identifier: 07640142570592
• UDI-Public: (01)07640142570592(10)207500(17)260530
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• 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 Expiration Date: 05/30/2026
• Device Catalogue Number: 350-010-004
• Device Lot Number: 207500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2023
• Initial Report FDA Received Date: 11/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRES (ASAHI SION BLUE); GUIDING CATHETER (6F LAUNCHER EBU 3.5)
• Patient Age: 45 YR
• Patient Sex: Male
• Patient Weight: 99 KG
• Patient Race: White