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

Model Number	US-36045-F-ST-H
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2026
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 not 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
Event description: hub of sheath broke off during insertion resulting in needing to open a new one.Type of procedure: no value found.Patient complications: no.Patient complications patient outcome: unknown.As reported device codes: 1188: detachment of device or device component.As reported patient codes: 9398: no clinical signs, symptoms or conditions.

• Brand Name: CATAPULT GUIDE SHEATH WITH HYDROPHILIC COATING 6 FR,45 CM, STRAIGHT
• 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: 25066228
• Report Number: 3003637635-2026-00007
• Device Sequence Number: 9792759
• Product Code: DYB
• UDI-Device Identifier: 04251244502096
• UDI-Public: 04251244502096
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: US-36045-F-ST-H
• Device Lot Number: 800393
• 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: 04/01/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/04/2026
• Supplement Report FDA Received Date: 06/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2024
• 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