MAUDE Adverse Event Report: CONTRACT MEDICAL INTERNATIONAL GMBH CATAPULT GUIDE SHEATH WITH HYDROPHILIC COATING 5FR, 60CM, STRAIGHT; INTRODUCER SHEATH

Model Number	FG-35060-001
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	09/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The problem is described as followed: standard le angiogram.5fr catapult inserted easily into patient.Dr.Went in with segregator cutting balloon and as they removed it the braiding of the sheath started to come apart as visualized under fluro.Dr.Had to partially remove sheath and go back in to retrieve the rest of the sheath braiding that was still in the body.Patient had some blood loss but is fully recovered and home.What troubleshooting steps took place? what troubleshooting steps, if any, resolved the issue? removal of sheath.What is the next course of action? replace product.Patient present at time of event? yes.Patient complications: bleeding, blood loss / hemorrhage.In the physician's opinion, did the device or procedure cause or contribute to the patient complication? yes.Please describe the way in which the device or procedure caused or contributed to the patient complication? device broke in patient body- it was fully removed but took time and created some blood loss.Medical or surgical interventions: removal of sheath.Patient admitted to hospital beyond the standard of care: no.Patient outcome: fully recovered.As reported device codes: 1188: detachment of device or device component.As reported patient codes: 9131: hemorrhage, minor.Type of procedure: lower extremity angiogram.Device/procedure outcome: original device used, procedure completed.Patient outcome: f11: minor injury/ illness / impairment, f14: prolonged episode of care.
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 examines the dhr, ncrs, and ecos will be done as part of root cause investigation.
Additional Manufacturer Narrative
Initial report submitted on 22 october 2025, per mfr #: 3003637635-2025-00013.The complaint device was returned.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 external - undeterminable.
Event or Problem Description
The problem is described as followed: standard le angiogram.5fr catapult inserted easily into patient.Dr.Went in with serrenator cutting balloon and as they removed it the braiding of the sheath started to come apart as visualized under fluro.Dr.Had to partially remove sheath and go back in to retrieve the rest of the sheath braiding that was still in the body.Patient had some blood loss but is fully recovered and home.What troubleshooting steps took place? what troubleshooting steps, if any, resolved the issue: removal of sheath.What is the next course of action? replace product patient present at time of event? yes patient complications: bleeding, blood loss / hemorrhage in the physician's opinion, did the device or procedure cause or contribute to the patient complication? yes please describe the way in which the device or procedure caused or contributed to the patient complication? device broke in patient body- it was fully removed, but took time and created some blood loss medical or surgical interventions: removal of sheath patient admitted to hospital beyond the standard of care: no patient outcome: fully recovered.As reported device codes: 1188: detachment of device or device component as reported patient codes: 9131: hemorrhage, minor type of procedure: lower extremity angiogram device/procedure outcome: original device used, procedure completed patient outcome: f11: minor injury/ illness / impairment, f14: prolonged episode of care.

• Brand Name: CATAPULT GUIDE SHEATH WITH HYDROPHILIC COATING 5FR, 60CM, 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 str. 37; dresden, 01277 ; GM 01277
• MDR Report Key: 23355600
• Report Number: 3003637635-2025-00013
• Device Sequence Number: 12977747
• Product Code: DYB
• UDI-Device Identifier: 04251244502065
• UDI-Public: 04251244502065
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2025

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-35060-001
• Device Catalogue Number: US-35060-F-ST-H
• Device Lot Number: 801163
• 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: 09/22/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/22/2025
• Supplement Report FDA Received Date: 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2025
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown