MAUDE Adverse Event Report: CONTRACT MEDICAL INTERNATIONAL GMBH CATAPULT GUIDE SHEATH, 5F, 90CM, STRAIGHT, HYDROPHILIC COATED; INTRODUCER SHEATH

Model Number	FG-35090-001
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	09/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The problem was described as: "i did notice physician struggling to advance sheath upon insertion.We did not see any obvious anatomical challenges on angio.Physician performed intervention successfully.Upon removal, physician said the sheath became "stuck" and he had to use force to pull it out and then the plastic portion tore and the braided portion began to unravel.The doctor decided to use a scalpel to cut the sheath above the damaged portion in order to insert a wire to keep access.He successfully did this and was able to put a short 7 french sheath in.No complications, nothing left inside patient.Minimal blood loss." what troubleshooting steps, if any, resolved the issue? he tried to insert a balloon in to trap his wire so he wouldn't lose access.That did not work.Patient present at time of event? yes, patient complications: hematoma, 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? physician said it lost its integrity and began to unravel.Medical or surgical interventions: physician had to cut the sheath with a scalpel above the portion that broke/unraveled so that he could put another wire in to advance another sheath into the artery.Patient admitted to hospital beyond the standard of care: no patient outcome: fully recovered type of procedure: lower extremity angiogram with intervention device/procedure outcome: procedure completed, unable to use device - attempted, non-distributor product used patient outcome: f2301: additional device required reported device codes: 1280: difficult to advance into artery, 1346: difficult to remove, 1048: break as reported patient codes: 9128: hemorrhage.
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 an evaluation.The dhr review, which examines the dhr, ncrs, and ecos will be done as part of the root cause investigation.
Event or Problem Description
The problem was described as: "i did notice physician struggling to advance sheath upon insertion.We did not see any obvious anatomical challenges on angio.Physician performed intervention successfully.Upon removal, physician said the sheath became "stuck" and he had to use force to pull it out and then the plastic portion tore and the braided portion began to unravel.The doctor decided to use a scalpel to cut the sheath above the damaged portion in order to insert a wire to keep access.He successfully did this and was able to put a short 7 french sheath in.No complications, nothing left inside patient.Minimal blood loss." what troubleshooting steps took place? what troubleshooting steps, if any, resolved the issue?: he tried to insert a balloon in to trap his wire so he wouldn't lose access.That did not work.What is the next course of action?: patient recovered.Patient present at time of event?: yes.Patient complications: hematoma, 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?: physician said it lost its integrity and began to unravel medical or surgical interventions: physician had to cut the sheath with a scalpel above the portion that broke/unraveled so that he could put another wire in to advance another sheath into the artery.Patient admitted to hospital beyond the standard of care: no.Patient outcome: fully recovered.Type of procedure: lower extremity angiogram with intervention.Device/procedure outcome: procedure completed, unable to use device - attempted,non distributor product used.Patient outcome: f2301: additional device required.Reported device codes: 1280: difficult to advance into artery, 1346: difficult to remove, 1048: break as reported patient codes: 9128: hemorrhage.On 24.09.2024 the customer provided below additional info: can you please describe the patient anatomy during operation? anatomy: didn't seem to have a steep bifurcation or any obvious calcification or scar tissue but the physician did seem to use force to insert the sheath.Was there increased resistance felt during the procedure, e.G.Due to calcification or scar tissue? was the dilator used during sheath relocation? dilator was not used to relocate sheath.No power injector used.The other devices used for the case were a shockwave balloon, i believe a 3.0.We were treating a tibial vessel.And then the.014 whisper wire.
Additional Manufacturer Narrative
Initial report submitted on 24 sep 2024, per mfr report #: 3003637635-2024-00017.The dhr review and investigation performed on the returned device showed that there is no production or design issue that can lead to the defect which caused the complaint case.According to the additional information provided by the customer, the dilator was not used during sheath removal.According to the ifu of the device, dilator usage during withdrawal is a must.The root cause has been established as user error.

• Brand Name: CATAPULT GUIDE SHEATH, 5F, 90CM, STRAIGHT, HYDROPHILIC COATED
• 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 GMBH; lauensteiner strasse. 37; dresden, 01277 ; GM 01277
• Manufacturer Contact: juliana vaz neurnberger ; vazni 848; hradec kralove, 50003 ; EZ 50003
• MDR Report Key: 20289696
• Report Number: 3003637635-2024-00017
• Device Sequence Number: 8012368
• Product Code: DYB
• UDI-Device Identifier: 04251244502072
• UDI-Public: 04251244502072
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 11/11/2024

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-35090-001
• Device Catalogue Number: US-35090-F-ST-H
• Device Lot Number: 800276
• 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: 09/17/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/24/2024
• Supplement Report FDA Received Date: 11/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2024
• 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
• Patient Sex: Unknown