MAUDE Adverse Event Report: CONTRACT MEDICAL INTERNATIONAL GMBH BIOTRONIK FORTRESS INTRODUCER SHEATH SYSTEM, 7F STRAIGHT 45CM

Model Number	FG-07551-002
Medical Device Problem Codes	Fracture (1260); Material Separation (1562); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During removal of a biotronik fortress 7f 45cm introducer, the sheath "disintegrated" when it was removed.
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
Heraeus medevio received the device on 3rd november 2023.The contents of the box were examined to ensure no damage was present in the internal or external packaging.The external box was checked and no damage was found.Then, the box was opened to check the contents.Three layers of packaging protected the returned samples: 1 biohazard bag (sealed), 1 sealed plastic biohazard bag, and a ziplock bag containing the returned product.All layers of packaging were intact prior to investigation.Only the shaft with attached hva was returned for evaluation.The dilator was not returned.For the returned product, the sample was kept in the ziplock back to avoid loss of fluid, further contamination, or changes in the sample.The sheath shaft came apart at about ¼ of the way from the proximal end.The coils were stretched which would indicate the tear could have happened during removal.Further examination of the sample showed the distal side of the sheath was mostly intact but wavily deformed (the lower half of shaft).The separation of coils can be observed by the gaping of the coils and partial folding of the sheath material in between.There is no evidence of damage of the tip.Cmi performed dhr review of the complaint lot 686654.No abnormalities that could be related to the complaint case were found.While no tensile strength testing could be conducted on the returned sample at this time based on the article 89 eu mdr requirements, we use data from previous complaints with a similar failure mode to ensure the sheath shaft was within specification (15n per iso 10555-1, iso 11070).Tensile strength data for the 3 recent similar complaints investigations were reviewed.In all cases, the tensile data was exceeded the requirement more than twice.The data from the in-process testing at manufacturer site shows the trend of tensile test values is stable and well above the specification.The true root cause was not determined.According to the complaint description and the results of previous complaints investigations, there is no indication that the incident is related to the manufacturing process or design failure.

• Brand Name: BIOTRONIK FORTRESS INTRODUCER SHEATH SYSTEM, 7F 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 ; GM 01277
• Manufacturer Contact: juliana nuernberger ; lauensteiner strasse 37; dresden, 01277 ; GM 01277
• MDR Report Key: 18169787
• Report Number: 3003637635-2023-00003
• Device Sequence Number: 7661263
• Product Code: DYB
• UDI-Device Identifier: 04251244500887
• UDI-Public: 04251244500887
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K203179
• 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): 12/22/2023

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: 03/31/2026
• Device Model Number: FG-07551-002
• Device Catalogue Number: 452382
• Device Lot Number: 721526
• 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: 10/23/2023
• Supplement Date Received by Manufacturer: 10/23/2023
• Initial Report FDA Received Date: 11/20/2023
• Supplement Report FDA Received Date: 12/22/2023
• 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
• Patient Sex: Unknown