MAUDE Adverse Event Report: CONTRACT MEDICAL INTERNATIONAL GMBH CATAPULT HYDROPHYLIC COATED INTRODUCER SHEATH SYSTEM FINISHED GOOD 8FR 900MM

Model Number	FG-38090-001
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The hcp pulled sheath from customers shelf, opened it up and inspected which os when we discovered that the hub can be turned about 1/4 turn both ways.Catheter seems like it's tight and together but the hub is loose.Patient present at time of event?: no patient complications: no.
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
The device was not returned for an evaluation.The dhr review did not indicate any relation to the complained event.The detail mentioned in complaint description which is "hub can be turned about 1/4 turn both ways" is not a malfunction.It is a feature and part of the design that the swivel nut can be rotated slightly back and forth when connected.The physician did not report any loose connection.On the other hand, the complained device was not returned to heraeus medevio and investigations were held with the review of batch record and the picture provided by the customer.According to the investigations done on batch record, ncrs, and ecos related to the complained lot, there is no detail that can lead hub to turn around more and/or be more loose than the designed device.

• Brand Name: CATAPULT HYDROPHYLIC COATED INTRODUCER SHEATH SYSTEM FINISHED GOOD 8FR 900MM
• Common Device Name: INTRODUCER SHEATH
• Manufacturer (Section D): CONTRACT MEDICAL INTERNATIONAL GMBH; lauensteinerstrasse 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: 18527010
• Report Number: 3003637635-2024-00001
• Device Sequence Number: 12727361
• Product Code: DYB
• UDI-Device Identifier: 04251244502324
• UDI-Public: 04251244502324
• Combination Product (Y/N): N
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2024

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-38090-001
• Device Catalogue Number: US-38090-F-ST-H
• Device Lot Number: 724368
• 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: 12/20/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/17/2024
• Supplement Report FDA Received Date: 05/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/20/2023
• 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