MAUDE Adverse Event Report: CONTRACT MEDICAL INTERNATIONAL GMBH CATAPULT, HYDROPHILLIC COATED INTRODUCER SHEATH SYSTEM, 7F, 45 CM, STRAIGHT

Model Number	FG-37045-001
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer was made aware about the reported case by the fda.A copy of the medwatch form (report number mw5168351) was sent to the manufacturer on 09 april 2025.The initial reporter asked to remain confidential and therefore information in section e1 could not be fully completed.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 examines the dhr, ncrs, and ecos was done as part of root cause investigation.
Event or Problem Description
The problem was described as: "a planned right lower extremity angiogram with intervention was performed via a 7 fr x 45 cm sheath that was placed by dr.(b)(6) in the right dorsalis pedis artery.At the conclusion of the procedure, an attempt was made by dr.(b)(6) to withdraw the sheath.The sheath experienced a fracture which made it impossible to directly remove the device.The entrapped sheath was successfully removed with surgical exposure and direct arterial repair.The patient was admitted overnight for observation and was discharged the following day." type of procedure: right lower extremity angiogram.Operator of device: health professional.Type of event: malfunction.Device available for evaluation: no.
Additional Manufacturer Narrative
Initial report submitted on 20 february 2025, per mfr#: 3003637635-2025-00010.The complaint devices was not returned.Therefore, testing of the actual device in the reported adverse event is not 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.There is no process related root cause found from dhr review.Root cause is established as undeterminable.
Event or Problem Description
The problem was described as: "a planned right lower extremity angiogram with intervention was performed via a 7 fr x 45 cm sheath that was placed by dr.(b)(6) in the right dorsalis pedis artery.At the conclusion of the procedure, an attempt was made by dr.(b)(6) to withdraw the sheath.The sheath experienced a fracture which made it impossible to directly remove the device.The entrapped sheath was successfully removed with surgical exposure and direct arterial repair.The patient was admitted overnight for observation and was discharged the following day." type of procedure: right lower extremity angiogram, operator of device: health professional, type of event: malfunction, device available for evaluation? no.

• Brand Name: CATAPULT, HYDROPHILLIC COATED INTRODUCER SHEATH SYSTEM, 7F, 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: 21991666
• Report Number: 3003637635-2025-00010
• Device Sequence Number: 20952385
• Product Code: DYB
• UDI-Device Identifier: 04251244502201
• UDI-Public: 04251244502201
• Combination Product (Y/N): N
• 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: Other
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2025

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-37045-001
• Device Catalogue Number: US-37045-F-ST-H
• Device Lot Number: 800129
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/09/2025
• Supplement Report FDA Received Date: 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/26/2024
• 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; Hospitalization
• Patient Age: 79 YR
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic
• Patient Race: White