MAUDE Adverse Event Report: CONTRACT MEDICAL INTERNATIONAL GMBH BIOTRONIK FORTRESS INTRODUCER SHEATH SYSTEM, 100CM 6F STRAIGHT

Model Number FG-06552-001A

Device Problems Entrapment of Device (1212); Difficult to Remove (1528); Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/13/2018

Event Type  malfunction  

Manufacturer Narrative

The root cause of the incident is unknown at the time of the initial report.The complaint device was not returned yet.The dhr review of the complaint lot 611628 and related subassembly lots 610547 and 610548 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 Description

Upon finishing a case provider was removing the long sheath from inside the body.Physician met heavy resistance upon removal.Physician then noticed the sheath had frayed and eventually broke off in the body when manual pressure had to be applied to control bleeding.Patient was admitted for planned intervention of left chronic occlusion of popliteal artery.Pta unsuccessful.Upon removal of sheath, sheath degraded.Advanced without difficulty.Emergency cut-down performed of bilateral groins, sheath removed.

Manufacturer Narrative

The dhr review of the complaint lot 611628 and related subassembly lots 610547 and 610548 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.Sample evaluation: the sample was sent for decontamination to the external laboratory.After the decontamination, the sample was inspected and the reported issue was confirmed.Complaint investigation information: before start of investigation the customer was asked by manufacturer for additional information on 13.03.2019 with following questions: 1) was the dilator in place prior to removal of the sheath? 2) was there any calcification? 3) was there any problem during advancing? after two weeks from the date of the request the customer was unable to get answers to manufacturer questions.Based on this fact manufacturer consider, that the dilator was in place prior to removal of the sheath.For the investigation purposes, the returned device was tested for the tensile force of the sheath.The sheath was initially put into the water bath (37°c) for 2 hours to simulate the use in the patient.Subsequently, the destructive pull tests were performed on 7 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 defines that the tensile strength which will leads to failure of the sheath must be >35n.According to the results, the iso requirement as well as manufacturer's internal document and customer's requirements for the tensile force were fulfilled for all 7 samples from the returned device.The results of the destructive pull tests of the all subassembly lots which are related to the complaint lot were above the required limit.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." the exact root cause could not be determined.Based on the complaint investigation, there is no indication that the incident was caused by manufacturer's design or manufacturing process failure.Based on the information provided from customer, the sheath was removed despite heavy resistance upon removal.This probably led to the sheath being crushed in the body and finally broke off.After considering all available information provided by customer and information from the complaint investigation, the most likely root cause is end user error.

• Brand Name: BIOTRONIK FORTRESS INTRODUCER SHEATH SYSTEM, 100CM 6F STRAIGHT
• Type of Device: INTRODUCER SHEATH
• Manufacturer (Section D): CONTRACT MEDICAL INTERNATIONAL GMBH; lauensteiner strasse 37; dresden, germany 01277 ; GM 01277
• MDR Report Key: 8331226
• MDR Text Key: 137417160
• Report Number: 3003637635-2019-00004
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 04251244500085
• UDI-Public: 04251244500085
• Combination Product (y/n): N
• PMA/PMN Number: K153197
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/24/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 05/12/2016
• Device Model Number: FG-06552-001A
• Device Catalogue Number: 386595
• Device Lot Number: 611628
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2019
• Initial Date Manufacturer Received: 01/29/2019
• Initial Date FDA Received: 02/12/2019
• Supplement Dates Manufacturer Received: 01/29/2019
• Supplement Dates FDA Received: 04/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 71 YR