MAUDE Adverse Event Report: CONTRACT MEDICAL INTERNATIONAL GMBH CATAPULT GUIDE SHEATH, 6F, 45CM, STRAIGHT, HYDROPHILIC COATED; INTRODUCER SHEATH

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	02/09/2024
Type of Reportable Event	Malfunction
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 dhr review, which examines the dhr, ncrs, and ecos will be done as part of the root cause investigation.
Event or Problem Description
The customer reported as follows: "case was coming to the end and as the physician was pulling the sheath out the sheath unraveled inside the patient." patient present at time of event?: yes patient complications: no patient complications device/procedure outcome: procedure completed, original device used type of procedure: angiogram.
Additional Manufacturer Narrative
The device was not returned back to the manufacturer for the evaluation.Based on similar complaints for devices which were investigated and tested, it is likely the sheath experienced a similar failure mode.Additionally, dhr review did not provide any evidence the failure could have been process related.From the complaint description, the failure would have possibly been caused by the effects of sheath kinking and pull force through a complex anatomical path.The kinking would have occurred because of the complex anatomical path leading to weakening or breakage of the sheath while the removal process would have resulted in the coils separating from the broken shaft section.Since it was not possible to get additional information about the applied procedure after the operation, it is unknown whether the clinician had inserted the dilator during removal of sheath as required per ifu.However it is a possibility that the dilator might have not been used and it might have played a role on sheath unravelling.Without the device being available for evaluation, conclusive data could not be gathered for this complaint.Based on similar occurrences, the failure was unlikely to be a result of a design or process issue as shown in previous complaints.This would be supported by the fact that the catapult family of sheaths was shown to pass kink stability and tensile strength test requirements, and there were no manufacturing irregularities.It is possible that the sheath failure was a result of subsequent stresses introduced due to the difficult path leading to unintended breakage during removal of the sheath from the patient.Since it was not possible to get additional information about the applied procedure after the operation, it is unknown whether the clinician had inserted the dilator during removal of sheath as required per ifu.However it is a possibility that the dilator might have not been used and it might have played a role on sheath unravelling.

• Brand Name: CATAPULT GUIDE SHEATH, 6F, 45CM, 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 nuernberger ; lauensteiner strasse 37; dresden, 01277 ; GM 01277
• MDR Report Key: 18941405
• Report Number: 3003637635-2024-00008
• Device Sequence Number: 19547690
• Product Code: DYB
• UDI-Device Identifier: 04251244502096
• UDI-Public: 04251244502096
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 03/20/2024

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-36045-001
• Device Catalogue Number: US-36045-F-ST-H
• Device Lot Number: 752277
• 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: 02/20/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/20/2024
• Supplement Report FDA Received Date: 05/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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