MAUDE Adverse Event Report: CONTRACT MEDICAL INTERNATIONAL GMBH CATAPULT GUIDE SHEATH WITH HYDROPHILIC COATING 6 FR,60 CM,STRAIGHT; INTRODUCER SHEATH

Catalog Number	US-36060-F-ST-H
Medical Device Problem Codes	Fracture (1260); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer was made aware about the reported case by the fda.A copy of the medwatch form (report number: mw5187872) was sent to the manufacturer on 26.05.2026.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.
Event or Problem Description
"during the procedure dr.(b)(6) opened and prepped the catapult sheath according to the ifu and then inserted the sheath into the groin access.As he inserted the sheath, he felt something was off and quickly removed the sheath.At that point, the sheath was fully removed from the vessel, still intact, but it was observed that the sheath braiding came apart and was unraveling at the hub.The scrub tech quickly isolated the sheath to be returned for investigation and proceeded on with the procedure using a terumo destination sheath, which was inserted successfully into the vessel".What troubleshooting steps took place? what troubleshooting steps, if any, resolved the issue? no troubleshooting took place once the physician noticed the sheath hub unraveling.What is the next course of action? removed the sheath and opened up a different one, proceeded on with the procedure.As reported device codes: 1048: break, 1307: difficult to insert.As reported patient codes: 9398: no clinical signs, symptoms or conditions.

• 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: 25374843
• Report Number: 3003637635-2026-00008
• Device Sequence Number: 18507273
• Product Code: DYB
• UDI-Device Identifier: 04251244502140
• UDI-Public: 04251244502140
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 07/01/2026

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
• Device Catalogue Number: US-36060-F-ST-H
• Device Lot Number: 800577
• 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: 05/07/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/03/2026
• Supplement Report FDA Received Date: 07/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown