MAUDE Adverse Event Report: CONTRACT MEDICAL INTERNATIONAL GMBH CATAPULT, HYDROPHILIC COATED INTRODUCER SHEATH, 6F, 450 MM, STRAIGHT

Model Number	FG-36045-001
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported as follows: "while removing a peripheral balloon the hub came disconnected." patient present at time of event?: yes.Patient complications: no patient complications.Type of procedure: peripheral intervention.Device/procedure outcome: unable to use device - attempted,different device used (same model),procedure completed.Patient outcome: f26: no health consequences or impact.As reported device codes: 1188: detachment of device or device component.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 be returned for an evaluation.The dhr review, which examines the dhr, ncrs, and ecos will be done as part of the root cause investigation.
Additional Manufacturer Narrative
Initial report submitted on 04-jun-2024, per mfr report #: 3003637635-2024-00013.The dhr review and investigation performed on the returned device showed that there is no production or design issue that can lead to the defect which caused the complaint case.Root cause is undeterminable.

• Brand Name: CATAPULT, HYDROPHILIC COATED INTRODUCER SHEATH, 6F, 450 MM, STRAIGHT
• Common Device Name: INTRODUCER SHEATH
• Manufacturer (Section D): CONTRACT MEDICAL INTERNATIONAL GMBH; lauensteiner strasse 37; dresden,
• Manufacturer (Section G): CONTRACT MEDICAL INTERNATIONAL GMBH; lauensteiner strasse 37; dresden,
• Manufacturer Contact: juliana nuernberger ; lauensteiner strasse 37; dresden, 01277 ; GM 01277
• MDR Report Key: 19456632
• Report Number: 3003637635-2024-00013
• Device Sequence Number: 15446876
• Product Code: DYB
• UDI-Device Identifier: 04251244502096
• UDI-Public: 04251244502096
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2024

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 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: 05/28/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/04/2024
• Supplement Report FDA Received Date: 08/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/19/2024
• 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