MAUDE Adverse Event Report: CONTRACT MEDICAL INTERNATIONAL GMBH BIOTRONIK FORTRESS INTRODUCER SHEATH SYSTEM, 6F STRAIGHT 45CM

Model Number	FG-06551-001A
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Material Separation (1562); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2024
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 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: "little green cap with hole in middle on the side of the device popped off during procedure.Because of this, a lot of blood was lost and a transfusion had to be done." event occurred inside patient.Device parts didn't remain in the patient.There is patient injury and blood transfusion needed, due to loss of blood.
Additional Manufacturer Narrative
The device was returned for the evaluation.The device was shipped back in a cardbox box with the returned product packed in a saf-t-pak pouch (1 paper layer, 2 sealed plastic bag layers, and 1 pouch).The green cap was confirmed to be detached from the hva assembly.The sheath was still connected to the hva.The dilator was not included in the pouch.Upon closer inspection of the hva body, the visible portion of the snap feature looks undamaged.The lower half of the groove where the hva membrane seals against was found to have some blood which could have been lift-off spot for the cap to pop off.Additional inspection of the visible portions of the hva did not reveal any signs of damage around the cap snap feature or the membrane seal groove.Based on the observations presented above, there is no evidence suggesting a possible defective hva body or cap.The scenarios where removal of the cap would be possible would require defective components (process), insufficient snap feature (design), or high internal pressure buildup.Since the visual inspections did not reveal any damage or defects on the part, it is unlikely the components were faulty.Furthermore, there is no indication of a design flaw since it was shown the hva was designed to operate at pressure levels required by iso 11070 and verified successfully.The dhr review did not result in any indication that the cause is manufacturing process related.From the additional use information gathered from the customer, the sheath was used in combination with a power injector.Examination of the instructions for use (ifu) warning section for the fortress product line of sheaths indicates the device is not to be used with power injectors.Therefore, the cap popping off is a result of misuse of the device due to the stated warning and exposure to higher pressures introduced in the system with a power injector.Since the ifu stated the sheath was not for use with power injectors, the root cause is a user error.

• Brand Name: BIOTRONIK FORTRESS INTRODUCER SHEATH SYSTEM, 6F STRAIGHT 45CM
• 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
• Manufacturer Contact: juliana nuernberger ; lauensteiner strasse 37; dresden, 01277 ; GM 01277
• MDR Report Key: 18668382
• Report Number: 3003637635-2024-00004
• Device Sequence Number: 8518382
• Product Code: DYB
• UDI-Device Identifier: 04251244500078
• UDI-Public: 04251244500078
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K153197
• 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): 02/08/2024

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 Expiration Date: 02/28/2026
• Device Model Number: FG-06551-001A
• Device Catalogue Number: 386594
• Device Lot Number: 721432
• 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: 01/10/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/08/2024
• Supplement Report FDA Received Date: 05/10/2024
• 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