MAUDE Adverse Event Report: CONTRACT MEDICAL INTERNATIONAL GMBH BIOTRONIK FORTRESS INTRODUCER SHEATH SYSTEM, 45CM, 5F STRAIGHT

Model Number	FG-05551-001A
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/07/2019
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 was recently returned for evaluation, but the evaluation has not begun yet.The dhr review of the complaint lot 635542 and related subassembly lots 634264, 635559, 616978, 616981, 621032, 629544, 629989, 630820, 633674 and 633704 was performed and there was found no deviation which could contribute to the reported incident.The devices passed all 100% in process inspections 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.
Event or Problem Description
During angioplasty, the physician was treating up and over from the right side.When he was done treating he pulled the sheath out and the distal half broke off.He attempted to fish the sheath out with no luck - the hub was removed day of the incident and the distal portion was removed the following day.
Additional Manufacturer Narrative
The dhr review of the complaint lot 635542 and related subassembly lots 634264, 635559, 616978, 616981, 621032, 629544, 629989, 630820, 633674 and 633704 was performed and there was found no deviation which could contribute to the reported incident.The devices passed all 100% in process inspections and aql based inspections.The manufacturer informed manufacturing operators and qc inspectors about the complaint.The sample was sent for decontamination to the external laboratory.After the decontamination, the sample was inspected and the reported issue was confirmed.For the investigation purposes, the returned device was tested for the tensile force of the sheath.The sheath was initially put into the waterbath (37°c) for 2 hours to simulate the use in the patient.Subsequently, the destructive pull tests were performed on 4 samples cut from the returned device.As described in iso (b)(4), for the smallest outside diameter bigger or equal than 1,850mm, the minimum peak tensile force is 15n.Manufacturer's internal document technical specification and customer's requirements document define, that the tensile strength which will lead to failure of the sheath must be >35n.The iso requirement as well as manufacturer's internal document and customer's requirements for the tensile force were fulfilled for all 4 samples.The results of the destructive pull tests of all subassembly lots, which are related to the complaint lot, were above the required limit.The ifu states the following: section precautions: "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, the dilator was not in place during the removal.Based on the evaluation of information summarized from investigation of returned device, the most likely root cause is the user error (removal of the sheath without dilator in place).

• Brand Name: BIOTRONIK FORTRESS INTRODUCER SHEATH SYSTEM, 45CM, 5F STRAIGHT
• Common Device Name: INTRODUCER SHEATH
• Manufacturer (Section D): CONTRACT MEDICAL INTERNATIONAL GMBH; lauensteiner strasse 37; dresden, germany 01277 ; GM 01277
• MDR Report Key: 8264083
• Report Number: 3003637635-2019-00002
• Device Sequence Number: 11102041
• Product Code: DYB
• UDI-Device Identifier: 04251244500047
• UDI-Public: 04251244500047
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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): 02/26/2019

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: 04/30/2020
• Device Model Number: FG-05551-001A
• Device Catalogue Number: 386591
• Device Lot Number: 635542
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2019
• Initial Date Received by Manufacturer: 01/10/2019
• Supplement Date Received by Manufacturer: 01/10/2019
• Initial Report FDA Received Date: 01/21/2019
• Supplement Report FDA Received Date: 02/26/2019
• 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