MAUDE Adverse Event Report: CONTRACT MEDICAL INTERNATIONAL, GMBH BIOTRONIK FORTRESS INTRODUCER SHEATH, SINGLE PACKAGE, STRAIGHT 90 CM, 5F

Model Number	FG-05558-001
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/27/2020
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 to the manufacturer.Manufacturer performed dhr review of the complaint lot 663827 and related subassembly lots.No deviation was found in the records.Manufacturing department/qc inspectors were informed about this complaint.The customer confirmed that the device was used over the subclavia and in the radial artery.This would mean off label use of the device.
Event or Problem Description
Following problem description was provided to cmi by the customer through a complaint notification form: "during withdrawal a material fracture occurred just behind the hemostatic valve.The factured part had to be removed by surgery.".
Additional Manufacturer Narrative
Manufacturer performed dhr review of the complaint lot 663827 and related subassembly lots.No deviation was found in the records.Manufacturing department / qc inspectors were informed about this complaint.Manufacturer could not perform investigation of the complaint sample since the device was discarded in the hospital.Within the investigation manufacturer checked the results of the destructive pull tests of the all subassembly lots which are related to the complaint lot.Sub-05558-001 lots 663877 and 663878 were above the limit of 35n required by the customer.Trending of pull tests results form 2019 was reviewed.The average value of the results from the start / end of the molding process was around 50n.The complaint lot passed 100% in-process inspections and aql based inspection.The customer was asked for additional information needed for the investigation purposes, e.G.Whether the dilator was in place during withdrawal, what was the access point for fortress, if there was felt any resistance during the insertion / withdrawal.The following information was provided: only guide wire was in place during the withdrawal of the sheath, dilator was not inserted.There was a slight resistance felt during insertion.The access point was over a femoralis right and the fortress was then used over the subclavia and in the radial artery.The instructions for use, section indications states the following: the fortress introducer sheath system is intended to provide access and to facilitate percutaneous introduction of guide wires, catheters and other devices into the femoral, popliteal and infrapopliteal arteries while maintaining haemostasis during diagnostic and interventional procedures.Based on the information provided by the customer, the biotronik fortress introducer sheath was used over the subclavia and in the radial artery.This is in contradiction with instructions for use / intended use.The instructions for use, section warnings states following: do not attempt to advance or withdraw the introducer, guide wire, catheter, or other interventional device if resistance is felt.Use fluoroscopy to determine the cause.If the cause cannot be determined and corrected, discontinue the procedure and withdraw the introducer sheath.Continued advancement or retraction against resistance may result in serious injury, and/or breakage of the guide wire, introducer sheath, catheter or interventional medical device.Based on the information provided by the customer, there was felt a slight resistance during the insertion.This is a contradiction with instructions for use / intended use.The instructions for use, section precautions states following: do not attempt introducer sheath advancement or withdrawal without guide wire and dilator secured in place.Severe vascular damage and/ or injury may occur.Based on the information provided by the customer, a guide wire was in place during withdrawal but no dilator.This is a contradiction with instructions for use / intended use.Based on the complaint investigation, there is no indication that the incident was caused by manufacturer's design or manufacturing process failure.After considering all available information provided by the customer and information from the complaint investigation, the most likely root cause is end user error.

• Brand Name: BIOTRONIK FORTRESS INTRODUCER SHEATH, SINGLE PACKAGE, STRAIGHT 90 CM, 5F
• Common Device Name: INTRODUCER SHEATH
• Manufacturer (Section D): CONTRACT MEDICAL INTERNATIONAL, GMBH; lauensteiner strasse 37; dresden, 01277 ; GM 01277
• MDR Report Key: 10406058
• Report Number: 3003637635-2020-00003
• Device Sequence Number: 11360715
• Product Code: DYB
• UDI-Device Identifier: 04251244500580
• UDI-Public: 04251244500580
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K153197
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2020

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: 03/31/2022
• Device Model Number: FG-05558-001
• Device Catalogue Number: 444483
• Device Lot Number: 663827
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/30/2020
• Supplement Date Received by Manufacturer: 07/30/2020
• Initial Report FDA Received Date: 08/14/2020
• Supplement Report FDA Received Date: 10/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention