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

Model Number	FG-06551-001A
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Codes	Edema (1820); Hemostasis (1895); Numbness (2415); Blood Loss (2597); Device Embedded In Tissue or Plaque (3165)
Date of Event	10/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The dhr review of the complaint lot 654478 and related subassembly lots 654394, 658166, 656669, 656670 and 653512 was performed and there was found no deviation which could contribute to the reported incident.The device passed all 100% in process inspection and aql based inspections.The manufacturer informed manufacturing operators and qc inspectors about the complaint.No remedial actions were initiated at the time of the initial report, since the exact root cause was not determined yet.Since at the beginning limited information was provided by the customer to the manufacturer, an additional questions were raised by the manufacturer, which should help during investigation.It seems, based on the information regarding the incident received so far that the device was used in contradiction with the intended use of the device, described in the ifu.The indications in the ifu says following: "the fortress introducer sheath system is intended to provide access and to facilitate percutaneous introduction of guide wires, catheters and other device into the femoral, popliteal and infrapopliteal arteries while maintaining haemostasis during diagnostic and interventional procedures." it was confirmed by the customer, that an area of the treatment was the anterior interventicular artery.The access point was the radial.Since the device got broken, there was no functional valve which could stop the bleeding.
Event or Problem Description
Event description provided by customer representative: "the fortress 6f intriducer broke outside the patient during withdrawal.As it was bleeding a lot the arteria had to be clamped.Then it was tried to remove the introducer sheath again but the fortress broke inside the patient again.Therefore the patient had to be send to another hospital for emergency." event detailed description according biotronik complaint notification form id: (b)(4)."via radial artery.The fortress 6f introducer (45cm) broke outside the patient at withdrawal.Arteria was spasme-associated.So the withdrawal was difficult, but it happens often.As the valva was out of order, it was bleeding a lot.The physician needed to clamp the arteria.He tried again to remove the introducer but it broke again inside the patient.The patient has been hospitalized in another hospital in emergency.Today the patient suffers from an edema in the forearm and paresthesia also in the forearm.The patient is still at hospital.".
Additional Manufacturer Narrative
The dhr review of the complaint lot 654478 and related subassembly lots 654394, 658166, 656669, 656670 and 653512 was performed and there was found no deviation which could contribute to the reported incident.The device passed all 100% in process inspection and aql based inspections.The manufacturer informed manufacturing operators and qc inspectors about the complaint.Since the complaint device was not available, no sample evaluation can be done.It was confirmed, based on the all provided information regarding the incident received from the customer, that the device was used in contradiction with the intended use of the device, described in the ifu.The indications in the ifu says following: "the fortress introducer sheath system is intended to provide access and to facilitate percutaneous introduction of guide wires, catheters and other device into the femoral, popliteal and infrapopliteal arteries while maintaining haemostasis during diagnostic and interventional procedures." based on the information provided by the customer, the device was used for coronary angiography and coronary angioplasty.

• Brand Name: BIOTRONIK FORTRESS INTRODUCER SHEATH SYSTEM, STRAIGHT 45 CM, 6F
• Common Device Name: INTRODUCER SHEATH
• Manufacturer (Section D): CONTRACT MEDICAL INTERNATIONAL, GMBH; lauensteiner strasse 37; dresden, germany 01277 ; GM 01277
• MDR Report Key: 9443137
• Report Number: 3003637635-2019-00005
• Device Sequence Number: 16696304
• Product Code: DYB
• UDI-Device Identifier: 04251244500078
• UDI-Public: 04251244500078
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2020

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: 08/31/2021
• Device Model Number: FG-06551-001A
• Device Catalogue Number: 386594
• Device Lot Number: 654478
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/14/2019
• Supplement Date Received by Manufacturer: 11/14/2019
• Initial Report FDA Received Date: 12/10/2019
• Supplement Report FDA Received Date: 01/13/2020
• 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; Other; Required Intervention