MAUDE Adverse Event Report: CONTRACT MEDICAL INTERNATIONAL GMBH CATAPULT GUIDE SHEATH WITH HYDROPHILIC COATING 6 FR, 45 CM, MULTIPURPOSE; INTRODUCER SHEATH

Catalog Number	US-36045-F-MP-H
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The root cause of the incident is unknown at the time of the initial report.The complaint device will be returned for evaluation and investigation.The manufacturing record review including examination of nonconformity reports (ncr) and changes/deviations (eco/ccid/deviation) will be done as part of root cause investigation.
Event or Problem Description
Physician was doing an aortagram with run off in a patient with past medical history of surgery in the groin we were working in.Md made team aware it was going to be a difficult groin to work in.Case was going smoothly with a stent deployed and post dilated with a mustang balloon.When the physician went to remove the sheath over an amplatz wire, to out in a short 6fr sheath for closure it started to unravel over the wire and continued unraveling into the patients body.The proximal portion of the sheath was cut and removed over the wire, where a mustang balloon was put over the wire and inflated at the end of the sheath to secure it to be removed from the body.What troubleshooting steps took place? what troubleshooting steps, if any, resolved the issue?: mustang balloon inflation at end of sheath.As reported device codes: 1163: damaged/defective.

• Brand Name: CATAPULT GUIDE SHEATH WITH HYDROPHILIC COATING 6 FR, 45 CM, MULTIPURPOSE
• Common Device Name: INTRODUCER SHEATH
• Manufacturer (Section D): CONTRACT MEDICAL INTERNATIONAL GMBH; lauensteiner strasse. 37; dresden, 01277 ; GM 01277
• Manufacturer (Section G): CONTRACT MEDICAL INTERNATIONAL, SPOL. S R.O.; vazni 848; hradec kralove, 50003 ; EZ 50003
• Manufacturer Contact: juliana vaz neurnberger ; lauensteiner strasse. 37; dresden, 01277 ; GM 01277
• MDR Report Key: 25427163
• Report Number: 3003637635-2026-00009
• Device Sequence Number: 18713328
• Product Code: DYB
• UDI-Device Identifier: 04251244502140
• UDI-Public: 04251244502140
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K221914
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2026

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: US-36045-F-MP-H
• Device Lot Number: 800280
• 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: 05/12/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/08/2026
• Supplement Report FDA Received Date: 07/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2024
• 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: Unknown