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

Model Number	FG-36045-001
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	12/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial emdr report submitted on 30.01.2026 per emdr # 3003637635-2026-0002.The complaint device was not returned.The manufacturing record review done on eco and ncr does not show any root causes to the failure code.In the absence of the returned complaint device, and based solely on the information available, it is not possible to perform additional testing to verify the material properties of the shaft or to determine when or how the damage occurred.Therefore, root cause is undeterminable.
Event or Problem Description
The problem is described as followed: "this record was auto submitted by the ecn on behalf of the user.Information may be incomplete.Ecn event description: null" - as reported device codes: 1188: detachment of device or device component.Type of procedure: angiography.As reported device codes: 1188: detachment of device or device component.Device/procedure outcome: procedure cancelled/rescheduled, unable to use device - attempted.Patient present at time of event? yes patient complications: no patient complications.Patient outcome: fully recovered.Patient outcome: f26: no health consequences or impact.As reported patient codes: 9398: no clinical signs, symptoms or conditions.No other information has been provided and the customer agreed to proceed with the investigation.The customer has provided additional pictures of the complaint device.
Additional Manufacturer Narrative
With the information available on 23 december 2025, the incident was assessed as not reportable, as the patient outcome was f26: no health consequences or impact and the device part that detached was not specified.The failure mode and its potential severity could not be determined.After receiving additional information on 21 january 2026, the incident is now considered as reportable, as it meets the requirements of 21 cfr 803.If the malfunction were to recur, it could result in a serious injury.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 dhr review, which examines the dhr, ncrs, and ecos, will be conducted as part of the root cause investigation.
Event or Problem Description
Heraeus medevio dresden had received a customer complaint notification from customer.The only information provided in the field "event description" is the following: "this record was auto submitted by the ecn on behalf of the user.Information may be incomplete.Ecn event description: null" - as reported device codes: 1188: detachment of device or device component.Type of procedure: angiography.As reported device codes: 1188: detachment of device or device component.Device/procedure outcome: procedure cancelled/rescheduled, unable to use device - attempted.Patient present at time of event? yes.Patient complications: no patient complications.Patient outcome: fully recovered patient outcome: f26: no health consequences or impact.As reported patient codes: 9398: no clinical signs, symptoms or conditions.Additional information provided by distributor on 01/21/2026: "distributor has provided additional images for this complaint.The images suggest that the sheath was detached from the valve.".

• Brand Name: CATAPULT GUIDE SHEATH WITH HYDROPHILIC COATING 6F; 45CM; 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: 24219774
• Report Number: 3003637635-2026-00002
• Device Sequence Number: 9265683
• Product Code: DYB
• UDI-Device Identifier: 04251244502096
• UDI-Public: 04251244502096
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 03/03/2026

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 Expiration Date: 09/08/2026
• Device Model Number: FG-36045-001
• Device Lot Number: 752276
• 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: 12/23/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/30/2026
• Supplement Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown