MAUDE Adverse Event Report: CONTRACT MEDICAL INTERNATIONAL GMBH CATAPULT, HYDROPHILLIC COATED INTRODUCER SHEATH SYSTEM, 8F, 60CM

Model Number	FG-38060-001
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 exames the dhr, ncrs, and ecos will be done as part of the root cause investigation.
Event or Problem Description
The problem was described as: "the hub on the 8x60 catapult comes off during procedure causing leaking, this happened on two in a row".As reported device codes: 1188: detachment of device or device component as reported patient codes: 9398: no clinical signs, symptoms or conditions.Device/procedure outcome: unable to use device - attempted,procedure - no information available patient outcome: f26: no health consequences or impact.Returned product expected: no.
Event or Problem Description
The problem was described as: "the hub on the 8x60 catapult comes off during procedure causing leaking, this happened on two in a row".As reported device codes: 1188: detachment of device or device component as reported patient codes: 9398: no clinical signs, symptoms or conditions device/procedure outcome: unable to use device - attempted,procedure - no information available patient outcome: f26: no health consequences or impact returned product expected: no.On 10.03.2025 additional detail is requested on power injector usage and lot number.Customer provided below answer on the same day."response from customer: "they opened another catapult sheath, all the details i put in the original complaint are all i have, i apologize." a ship history was performed and identified batch 800427.Please perform your dhr using that batch number.".
Additional Manufacturer Narrative
Initial report submitted on 28 march 2025, per mfr #: 3003637635-2025-00007.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.

• Brand Name: CATAPULT, HYDROPHILLIC COATED INTRODUCER SHEATH SYSTEM, 8F, 60CM
• 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 nuernberger ; lauensteiner strasse. 37; dresden, 01277 ; GM 01277
• MDR Report Key: 21717836
• Report Number: 3003637635-2025-00007
• Device Sequence Number: 4514832
• Product Code: DYB
• UDI-Device Identifier: 04251244502317
• UDI-Public: 04251244502317
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 04/30/2025

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-38060-001
• Device Catalogue Number: US-38060-F-ST-H
• Device Lot Number: 800427
• 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: 03/03/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/28/2025
• Supplement Report FDA Received Date: 04/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/17/2024
• 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
• Patient Sex: Unknown