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	Break (1069); Fracture (1260); Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/12/2026
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 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
Event description: the sheath was placed in left groin and was up and over to the right lower extremity.The surgeon said the left groin was very scarred.Upon completion of the intervention the surgeon was removing the sheath when it met resistance due to the scar tissue.He noticed it started to unravel and eventually came apart.He then attempted to snare the fractured portion but was unsuccessful.He cut down on the left groin and was able to safely extract the fractured portion.The patient had no complications and was discharged the following day.What troubleshooting steps took place? what troubleshooting steps, if any, resolved the issue?: attempted snare.Then surgical cut down to extract fractured portion.What is the next course of action?: surgical extraction was successful.As reported device codes: 1188: detachment of device or device component.Device/procedure outcome: procedure completed,unable to use device - attempted.

• 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: 24980312
• Report Number: 3003637635-2026-00006
• Device Sequence Number: 16081920
• Product Code: DYB
• UDI-Device Identifier: 04251244502140
• UDI-Public: 04251244502140
• 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: Distributor
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2026

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 Catalogue Number: US-36060-F-ST-H
• Device Lot Number: 800418
• 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: 03/24/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/24/2026
• Supplement Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (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