MAUDE Adverse Event Report: CONTRACT MEDICAL INTERNATIONAL GMBH CATAPULT, HYDROPHILIC COATED INTRODUCER SHEATH, 7F, 450 MM, STRAIGHT

Model Number	FG-37045-001
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported as follows: the md did have a hard time advancing the sheath due to a very 'scarred groin.' the entire sfa into the common femoral was occluded with multiple previous stents noted.He started at the distal sfa and ballooned with multiple sizes.He was attempting to pull the sheath back to balloon the common femoral.When pulling back, the sheath snapped, thus breaking it and the stainless steel coils were pulled out and exposed.What troubleshooting steps took place? what troubleshooting steps, if any, resolved the issue?: new sheath what is the next course of action?: new sheath patient present at time of event?: yes patient complications: no patient outcome: f26: no health consequences or impact type of procedure: arterial input function (aif) as reported device codes: 1163: damaged/defective, 1188: detachment of device or device component as reported patient codes: 9398: no clinical signs, symptoms or conditions.
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.
Additional Manufacturer Narrative
Initial report submitted on 10 may 2024, per mfr report number: 3003637635-2024-00009.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.Root cause is undeterminable.
Event or Problem Description
The customer reported as follows: the md did have a hard time advancing the sheath due to a very 'scarred groin.' the entire sfa into the common femoral was occluded with multiple previous stents noted.He started at the distal sfa and ballooned with multiple sizes.He was attempting to pull the sheath back to balloon the common femoral.When pulling back, the sheath snapped, thus breaking it and the stainless steel coils were pulled out and exposed.What troubleshooting steps took place? what troubleshooting steps, if any, resolved the issue?: new sheath what is the next course of action?: new sheath patient present at time of event?: yes patient complications: no patient outcome: f26: no health consequences or impact type of procedure: arterial input function (aif) as reported device codes: 1163: damaged/defective, 1188: detachment of device or device component as reported patient codes: 9398: no clinical signs, symptoms or conditions additional information received on june 5th 2024: 1.What was the position of the sheath when it snapped? where was the tip located? "sheath was in the left groin.Tip was up and over the bifurcation" 2.Is it possible that the tip was stuck in the occluded section of the vasculature? "doubtful.Patient had multiple prior interventions.However, we were fixing the sfa" 3.Was a strong resistance felt, when the sheath was pulled back? "yes" a.If yes, was the root cause of the resistance analyzed? "the patient did have a very scarred groin due to past intervention." b.If yes, was the force increased to overcome the resistance? "force was increased in a attempt to pull back the sheath.".

• Brand Name: CATAPULT, HYDROPHILIC COATED INTRODUCER SHEATH, 7F, 450 MM, 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 GMBH; lauensteiner strasse 37; dresden, 01277 ; GM 01277
• Manufacturer Contact: juliana nuernberger ; lauensteiner strasse 37; dresden, 01277 ; GM 01277
• MDR Report Key: 19286901
• Report Number: 3003637635-2024-00009
• Device Sequence Number: 12666567
• Product Code: DYB
• UDI-Device Identifier: 04251244502201
• UDI-Public: 04251244502201
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2024

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 Expiration Date: 09/08/2026
• Device Model Number: FG-37045-001
• Device Catalogue Number: US-37045-F-ST-H
• Device Lot Number: 724940
• 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: 04/30/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/10/2024
• Supplement Report FDA Received Date: 07/02/2024
• 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: Required Intervention
• Patient Sex: Unknown