MAUDE Adverse Event Report: CONTRACT MEDICAL INTERNATIONAL GMBH CATAPULT GUIDE SHEATH; 7F; 45CM; STRAIGHT; INTRODUCER SHEATH SYSTEM

Model Number	FG-37045-001
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
7x45 catapult sheath sheared off inside patient.Access obtained through left common femoral artery with percutaneous needle and zip wire.Next a 6 f super sheath was attempted to be entered through the arteriotomy site but due to severe scarring from a previous fempop surgery, it had to be downsized to a 5 f super sheath.From here the site was dilated up using a 6 f then 7 f super sheath.Amplatz super stiff wire was placed up and over bifurcation for extra support and the 7x45 catapult sheath was inserted.Atherectomy and angioplasty were performed and upon removing the 7 f catapult sheath sheared off inside the patient.Wire access was maintained and a 5 mm charger balloon was advanced into pt just beyond the end of the sheath.Balloon was inflated and then used to pull sheared off portion of sheath toward the arteriotomy site.A small incision was made in the left groin area and hemostats were used to grab sheath and remove from the body.7 super sheath was then inserted and 7 f celt device was used for closure.Outcome of procedure- patient stable at discharge damaged product discarded by staff replacement item requested." as reported device codes: 1188: detachment of device or device component.As reported patient codes: 9398: no clinical signs, symptoms or conditions.Device/procedure outcome: procedure completed, unable to use device - attempted, different device used (different model).Patient outcome: f19: surgical intervention.
Additional Manufacturer Narrative
The root cause of the incident is unknown at the time of the initial report.The complaint device will not be returned for an evaluation.The device was discarded by medical staff.The dhr review, which examines the dhr, ncrs, and ecos will be done as part of the root cause investigation.
Event or Problem Description
7x45 catapult sheath sheared off inside patient.Access obtained through left common femoral artery with percutaneous needle and zip wire.Next a 6 f super sheath was attempted to be entered through the arteriotomy site but due to severe scarring from a previous fempop surgery, it had to be downsized to a 5 f super sheath.From here the site was dilated up using a 6 f then 7 f super sheath.Amplatz super stiff wire was placed up and over bifurcation for extra support and the 7x45 catapult sheath was inserted.Atherectomy and angioplasty were performed and upon removing the 7 f catapult sheath sheared off inside the patient.Wire access was maintained and a 5mm charger balloon was advanced into pt just beyond the end of the sheath.Balloon was inflated and then used to pull sheared off portion of sheath toward the arteriotomy site.A small incision was made in the left groin area and hemostats were used to grab sheath and remove from the body.7 super sheath was then inserted and 7 f celt device was used for closure.Outcome of procedure- patient stable at discharge damaged product discarded by staff replacement item requested." as reported device codes: 1188: detachment of device or device component as reported patient codes: 9398: no clinical signs, symptoms or conditions device/procedure outcome: procedure completed,unable to use device - attempted,different device used (different model) patient outcome: f19: surgical intervention on 26.11.2024 customer provided additional information about the complaint: was a dilator used during removal of 7f catapult? a dilator was not used during removal of the catapult sheath.Was a force felt during removal of 7f catapult? force was felt during entry and removal as the site was very scarred from previous surgery.Force was felt during entry and removal as the site was very scarred from previous surgery.Can you provide the pictures regarding the complaint? no pictures available.What was the reason to switch from 7f super sheath to 7f catapult? swapped from 7f super sheath to 7f catapult because it was contralateral access up and over aortic bifurcation.Additionally, since it is an interesting case which includes device changes, would it be possible to set up a call with the catapult smfd investigators and the physician referenced below for our understanding of what exactly caused the sheath shearing off? the physician declines a conversation with the investigators.
Additional Manufacturer Narrative
Initial report submitted on 26-nov-2024 per mfr report #:.The device was not returned for an evaluation.The dhr/batch record review showed 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; 7F; 45CM; STRAIGHT
• Common Device Name: INTRODUCER SHEATH SYSTEM
• Manufacturer (Section D): CONTRACT MEDICAL INTERNATIONAL GMBH; lauensteiner strasse 37; dresden, saxony 01277 ; GM 01277
• Manufacturer (Section G): CONTRACT MEDICAL INTERNATIONAL S.R.O.; vazni 848; hradec kralove, 50003 ; EZ 50003
• Manufacturer Contact: juliana neurnberger ; lauensteiner strasse 37; dresden, saxony 01277 ; GM 01277
• MDR Report Key: 20786495
• Report Number: 3003637635-2024-00023
• Device Sequence Number: 17850734
• Product Code: DYB
• UDI-Device Identifier: 04251244502201
• UDI-Public: 04251244502201
• 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): 12/20/2024

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-37045-001
• Device Catalogue Number: US-37045-F-ST-H
• Device Lot Number: 800431
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/26/2024
• Supplement Report FDA Received Date: 12/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/17/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown