MAUDE Adverse Event Report: CONTRACT MEDICAL INTERNATIONAL GMBH CATAPULT, HYDROPHILLIC COATED INTRODUCER SHEATH SYSTEM 6F, 60CM

Model Number	FG-36060-001
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	01/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The root cause of the incident is unknown at time of the initial report.The complaint device will not be returned for an evaluation.The dhr review which examens the dhr, ncrs, and ecos will be done as part of the root cause investigation.
Event or Problem Description
The problem was described as: "sheath was removed with dilator and uncoiled inside patient".What is the next course of action? tried to snare sheath.Patient present at time of event? yes.Patient complications: bleeding, discomfort / pain, blood loss / hemorrhage.In the physician's opinion, did the device or procedure cause or contribute to the patient complication? yes.Please describe the way in which the device or procedure caused or contributed to the patient complication? sheath fell apart inside patient.Medical or surgical interventions: open procedure.Patient admitted to hospital beyond the standard of care: yes.Patient discharged from hospital? no.Patient outcome: unknown.Device/procedure outcome: procedure completed, unable to use device - attempted.Patient outcome: f08: hospitalization or prolonged hospitalization, f2301: additional device required, f1901: additional surgery.As reported device codes: 1188: detachment of device or device component as reported patient codes: 9128: hemorrhage 9205: pain, 9069: discomfort.
Additional Manufacturer Narrative
Initial report submitted on 11 february 2025, per mfr report #: 3003637635-2025-00003.The complaint devices was not returned.Therefore testing of the actual device in the reported adverse event is possible.The dhr/batch record review showed that there is no production or design issue that can lead to the defect which caused the complaint case.Root cause is underminable.
Event or Problem Description
The problem was described as: "sheath was removed with dilator and uncoiled inside patient" what is the next course of action?: tried to snare sheath.Patient present at time of event?: yes.Patient complications: bleeding, discomfort / pain, blood loss / hemorrhage.In the physician's opinion, did the device or procedure cause or contribute to the patient complication?: yes.Please describe the way in which the device or procedure caused or contributed to the patient complication?: sheath fell apart inside patient.Medical or surgical interventions: open procedure.Patient admitted to hospital beyond the standard of care: yes.Patient discharged from hospital?: no.Patient outcome: unknown.Device/procedure outcome: procedure completed,unable to use device - attempted patient outcome: f08: hospitalization or prolonged hospitalization, f2301: additional device required, f1901: additional surgery.As reported device codes: 1188: detachment of device or device component as reported patient codes: 9128: hemorrhage 9205: pain, 9069: discomfort.

• Brand Name: CATAPULT, HYDROPHILLIC COATED INTRODUCER SHEATH SYSTEM 6F, 60CM
• 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: 21354348
• Report Number: 3003637635-2025-00003
• Device Sequence Number: 15735097
• Product Code: DYB
• UDI-Device Identifier: 04251244502140
• UDI-Public: 04251244502140
• Combination Product (Y/N): N
• Initial Reporter State: DE
• 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): 03/21/2025

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 Model Number: FG-36060-001
• Device Catalogue Number: US-36060-F-ST-H
• Device Lot Number: 800091
• 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: 01/15/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/11/2025
• Supplement Report FDA Received Date: 03/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/19/2024
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Sex: Unknown