MAUDE Adverse Event Report: CONTRACT MEDICAL INTERNATIONAL GMBH CATAPULT, HYDROPHILIC COATED INTRODUCER SHEATH SYSTEM, 7F, 450MM, STRAIGHT

Model Number	FG-37045-001
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported as follows: "during closure dr went to remove sheath it split inhalf." what troubleshooting steps, if any, resolved the issue?: was able to remove without complications.Patient present at time of event?: yes.Patient complications: no patient complications.Type of procedure: angio.Device/procedure outcome: unable to use device - attempted, procedure completed patient outcome: f26: no health consequences or impact as reported device codes: 1048: break.As reported patient codes: 9398: no clinical signs, symptoms or conditions.
Additional Manufacturer Narrative
The root cause of the incident is unknown at the time of the initial report.The complaint device will not be returned for an evaluation.Information provided by the customer and the dhr review will be done as part of the root cause investigation.
Additional Manufacturer Narrative
Initial report submitted on 06 aug 2024, per mfr report#: 3003637635-2024-00015.The complaint device was not returned.Therefore, testing of the actual device in the reported case 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.Root cause is underminable.

• Brand Name: CATAPULT, HYDROPHILIC COATED INTRODUCER SHEATH SYSTEM, 7F, 450MM, 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 GMBH; lauensteiner strasse 37; dresden, 01277 ; GM 01277
• Manufacturer Contact: juliana vaz nuernberger ; lauensteiner strasse 37; dresden, 01277-, ; GM 01277,
• MDR Report Key: 19915154
• Report Number: 3003637635-2024-00015
• Device Sequence Number: 17982220
• Product Code: DYB
• UDI-Device Identifier: 04251244502201
• UDI-Public: 04251244502201
• 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): 09/02/2024

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-37045-001
• Device Catalogue Number: US-37045-F-ST-H
• Device Lot Number: 724940
• 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: 07/11/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/06/2024
• Supplement Report FDA Received Date: 09/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown