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	05/23/2024
Type of Reportable Event	Malfunction
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.The dhr review, which examines the dhr, ncrs, and ecos will be done as part of the root cause investigation.
Event or Problem Description
The customer reported as follows: "physician pulled sheath back up and over a very steep, tortuous, angulated, and calcified bifurcation.The sheath separated then separated." patient present at time of event?: yes patient complications: no patient complications type of procedure: angiogram superficial device/procedure outcome: procedure completed,different device used (same model)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.
Event or Problem Description
The customer reported as follows: "physician pulled sheath back up and over a very steep, tortuous, angulated, and calcified bifurcation.The sheath separated then separated." patient present at time of event?: yes.Patient complications: no patient complications.Type of procedure: angiogram superficial.Device/procedure outcome: procedure completed,different device used (same model)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.On 12.06.2024 the customer provided below additional information: 1.In which step of the procedure event occurred (advancing the sheath / relocation / removal)? removal.2.Please describe the patient anatomy during operation.Steel bifurcation, heavily calcified.3.Please describe the applied procedure in detail including all other used devices (product name, product code) and infusion liquids (product name, product code).Unknown.4.Was there increased resistance felt during the procedure, e.G.Due to calcification or scar tissue? unknown.5.What was the physician experience level on this type of treatment/procedure? how many similar operations has he done before? very experienced vascular surgeon with many successful procedures documented.
Additional Manufacturer Narrative
Initial report submitted on 04 jun 2024, per mfr report #: 3003637635-2024-00014.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.

• 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, 01277 ; GM 01277
• Manufacturer (Section G): CONTRACT MEDICAL INTERNATIONAL GMBH; lauensteiner strasse 37; dresden, 01277 ; GM 01277
• Manufacturer Contact: juliana nuernberger ; lauensteiner strasse 37; dresden, 01277 ; GM 01277
• MDR Report Key: 19456704
• Report Number: 3003637635-2024-00014
• Device Sequence Number: 6652434
• Product Code: DYB
• UDI-Device Identifier: 04251244502096
• UDI-Public: 04251244502096
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 07/26/2024

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: 752277
• 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: 05/30/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/04/2024
• Supplement Report FDA Received Date: 07/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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