MAUDE Adverse Event Report: CONTRACT MEDICAL INTERNATIONAL GMBH CATAPULT, HYDROPHILIC COATED INTRODUCER SHEATH, 6F, 450 MM, STRAIGHT

Model Number	FG-36045-001
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported as follows: "dr.Got access in left groin w catapult.Performed atherectomy in left leg.When exchanging catapult for short sheath, it came apart in patients body.Vascular surgery had to perform cut down on patient to remove the pieces" patient outcome: f1901: additional surgery patient present at time of event?: yes patient complications: surgery 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?: the sheath came apart in the patient medical or surgical interventions: vascular cutdown to remove sheath pieces patient admitted to hospital beyond the standard of care: yes patient discharged from hospital?: no patient outcome: expected to fully recover as reported device codes: 1188: detachment of device or device component type of procedure: peripheral angiogram.
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 28-may-2024, per mfr report #: 3003637635-2024-00010.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, power injector was used and dilator was not used during the procedure.According to the ifu of the device, power injector is not allowed to be used with the device and dilator usage during withdrawal is a must.Not using dilator during withdrawal, together with the tensile stresses during the removal process would have resulted in elongation, breakage, and coils separating from the broken shaft section.The root cause has been established as user error.
Event or Problem Description
The problem was described as: "dr.Got access in left groin w catapult.Performed atherectomy in left leg.When exchanging catapult for short sheath, it came apart in patients body.Vascular surgery had to perform cut down on patient to remove the pieces." patient outcome: f1901: additional surgery.Patient present at time of event?: yes.Patient complications: surgery.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?: the sheath came apart in the patient.Medical or surgical interventions: vascular cutdown to remove sheath pieces.Patient admitted to hospital beyond the standard of care: yes.Patient discharged from hospital?: no.Patient outcome: expected to fully recover.As reported device codes: 1188: detachment of device or device component.Type of procedure: peripheral angiogram.On 24.05.2024 customer provided below additional information: 1.In which step of the procedure event occurred (advancing the sheath / relocation / removal)? removal.2.Where was the access point? left femoral artery.3.In which part of the leg did the incident happen? left femoral artery.4.Please describe the patient anatomy during operation.Normal.5.Please describe the applied procedure in detail including all other used devices (product name, product code) and infusion liquids (product name, product code): diamond back , dbp-150solid145; armada 6x150x140-1013470-150; boston amplarz super stiff-m001465630; merit amplatz-iqa525; philips quick cross-518-034; v-18-m001468540; viper wire-vpr-gw-flex14; jade balloon- 583024022.6.Was there increased resistance felt during the procedure, e.G.Due to calcification or scar tissue? yes.Significant scarring resulted in resistance during insertion.7.What was the physician experience level on this type of treatment/procedure? how many similar operations has he done before? very experienced.He regularly performs these procedures.8.Was a power injector used? yes.9.Was the dilator used during removal? no.

• Brand Name: CATAPULT, HYDROPHILIC COATED INTRODUCER SHEATH, 6F, 450 MM, STRAIGHT
• Common Device Name: INTRODUCER SHEATH
• Manufacturer (Section D): CONTRACT MEDICAL INTERNATIONAL GMBH; lauensteiner strasse 37; dresden,
• Manufacturer (Section G): CONTRACT MEDICAL INTERNATIONAL GMBH; lauensteiner strasse 37; dresden,
• Manufacturer Contact: juliana nuernberger ; lauensteiner strasse 37; dresden, 01277 ; GM 01277
• MDR Report Key: 19403158
• Report Number: 3003637635-2024-00010
• Device Sequence Number: 6955881
• Product Code: DYB
• UDI-Device Identifier: 04251244502096
• UDI-Public: 04251244502096
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2024

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-36045-001
• Device Catalogue Number: US-36045-F-ST-H
• Device Lot Number: 800080
• 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: 05/16/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/28/2024
• Supplement Report FDA Received Date: 08/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/19/2024
• 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