MAUDE Adverse Event Report: Contract Medical International GmbH Catapult Guide Sheath with hydrophilic coating 6 Fr, 60 cm, straight; Introducer Sheath

Model Number	FG-36060-001
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Sheath was difficult to remove then it separated into 2 pieces.Distal broken end of sheath was removed via surgical cutdown.What troubleshooting steps took place? what troubleshooting steps, if any, resolved the issue? doctor was patient pulling back device/procedure outcome: unable to use device - attempted, procedure completed.
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 evaluation and investigation.The manufacturing record review including examination of nonconformity reports (ncr) and changes/deviations (eco/ ccid/ deviation) will be done as part of root cause investigation.

• Brand Name: Catapult Guide Sheath with hydrophilic coating 6 Fr, 60 cm, 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, Spol. S R.O.; vazni 848; hradec kralove, 50003 ; EZ 50003
• Manufacturer Contact: juliana vaz neurnberger ; lauensteiner strasse. 37; dresden, 01277 ; GM 01277
• MDR Report Key: 50728087
• Report Number: 3003637635-2026-00012
• Device Sequence Number: 16107158
• Product Code: DYB
• UDI-Device Identifier: 04251244502140
• UDI-Public: 04251244502140
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K221914
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/11/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: FG-36060-001
• Device Lot Number: 800577
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 09/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown