MAUDE Adverse Event Report: CONTRACT MEDICAL INTERNATIONAL GMBH CATAPULT, HYDROPHILLIC COATED INTRODUCER SHEATH SYSTEM 6F, 45 CM

Model Number	FG-36045-001
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 intitial report.The complaint device will not be returned for an evaluation.The dhr review which exames the dhr, ncrs, and ecos will be done as part of the root cause investigation.
Event or Problem Description
The problem was described as: "placed sheath, completed procedure, attempted to remove sheath, it was difficult, sheath valve cap broke off, removed sheath, continued to closure" patient present at time of event? yes patient complications: no patient complications as reported device codes: 1346: difficult to remove, 1188: detachment of device or device component.As reported patient codes: 9398: no clinical signs, symptoms or conditions type of procedure: leg angio.Device/procedure outcome: device out of service - explanted or removed, unable to use device - attempted, procedure completed.Patient outcome: f26: no health consequences or impact.
Additional Manufacturer Narrative
Initial report submitted on (b)(6) 2025 per: mfr # 3003637635-2025-00004.At the time the initial report was submitted it was indicated that the complaint device will not be returned for an evaluation (d9, h11 in the initial report).The manufacturer was informed on (b)(6) 2025 that the device will be returned to our facility.We received the complaint device on (b)(6) 2025 (d9).The investigation which included visual inspection of the complaint device and the dhr review was concluded on (b)(6) 2025.Dhr review done did not indicate any design or process issue which would cause the failure mode.Investigation of the device shows that the cap was intact to the sheath.On the other hand, it is found out that sheath was unravelled and elongated which can confirm that there were difficulties during removal of the sheath.However, it is not possible to estimate how elongation and unravelling was caused.It is possible that the sheath failure was a result of stresses introduced due to the difficult path leading to unintended breakage during removal of the sheath from the patient.However, additional information couldn't be gathered from the customer and it is not possible to further test the device.Therefore, root cause is undeterminable.
Event or Problem Description
The problem was described as: "placed sheath, completed procedure, attempted to remove sheath, it was difficult, sheath valve cap broke off, removed sheath, continued to closure".Patient present at time of event? yes.Patient complications: no patient complications.As reported device codes: 1346: difficult to remove, 1188: detachment of device or device component.As reported patient codes: 9398: no clinical signs, symptoms or conditions.Type of procedure: leg angio.Device/procedure outcome: device out of service: explanted or removed, unable to use device: attempted, procedure completed.Patient outcome: f26: no health consequences or impact.

• Brand Name: CATAPULT, HYDROPHILLIC COATED INTRODUCER SHEATH SYSTEM 6F, 45 CM
• 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: 21372036
• Report Number: 3003637635-2025-00004
• Device Sequence Number: 3758791
• Product Code: DYB
• UDI-Device Identifier: 04251244502096
• UDI-Public: 04251244502096
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 05/13/2025

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-36045-001
• Device Catalogue Number: US-36045-F-ST-H
• Device Lot Number: 800138
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 02/13/2025
• Supplement Report FDA Received Date: 05/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2024
• 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: Other
• Patient Sex: Unknown