MAUDE Adverse Event Report: CONTRACT MEDICAL INTERNATIONL GMBH DURASHEATH INTRODUCER SHEATH SYSTEM

Model Number FG-06090-002

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

Patient Problems No Consequences Or Impact To Patient (2199); Patient Problem/Medical Problem (2688)

Event Date 12/20/2018

Event Type  malfunction  

Manufacturer Narrative

The root cause of the incident is unknown at the time of the initial report.The complaint device was recently returned for evaluation, but evaluation has not begun yet.The dhr review of the complaint lot 650933 and related subassembly lots 651977 and 650936 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.No remedial actions were initiated at the time of initial report, since the exact root cause was not determined yet.The product is newly cleared (december 2018) in us, however not a single piece was yet sold in the us.The devices from the same product family manufactured by cmi are also sold in the us.Which means that us cross-reporting criteria 21cfr803.3 were met.Therefore, 30-day report will be submitted.

Event Description

Doctor treated the distal popliteal artery and crural arteries.Procedure time was about 75 to 90 minutes.The patient had scar tissue in the groin where the puncture was made.Also a patch was present in this groin and they made the puncture through this patch.This is something that is often done and normally never gives any problems.This was in the right groin.In the other groin the patient had a necrotic wound.Echo guided puncture.Than they advanced a short 5f sheath so they could please the guidewire.The placement of the 5f sheath was without any friction.Than they changed for the 6f 90cm sheath.Advancing was already a little bit difficult, they felt some resistance.The procedure was done.At the end of the procedure the patient was placed into bed and they wanted to retract the sheath.But it was completely stuck.They immediately noticed the sheath stretched a bit.So they placed the patient back on the table.Under angio they tried again to retract, but still it was completely stuck.The took a small 4x40x130 0.018 balloon catheter.They placed it distally from the tip of the sheath and tried pulling everything back with the balloon just in front of the sheath.They could retract it for about 5 cm.Then again it was stuck.They tried pulling a bit more and this was the moment the sheath (and also the balloon) both broke into two pieces.During the procedure the sheath was not moved.The patient had to go to the operating room where they successfully removed the sheath.The patient had very calcified arteries.However, there were no occlusions.

Manufacturer Narrative

The dhr review of the complaint lot 650933 and related subassembly lots 651977 and 650936 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 qc inspections.Sample evaluation: the sample was sent for decontamination.After the decontamination, the sample was inspected and the reported issue was confirmed.Complaint investigation information: as reported, advancing of the introducer was already a little bit difficult - they felt some resistance.At the end of the procedure, the sheath was completely stuck - the sheath was then pulled off over the resistance and broke in two pieces.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 2 samples cut from the returned device.As described in iso 11070:2014, for the smallest outside diameter >1,850mm, the minimum peak tensile force is 15n.Manufacturer's internal document technical specification defines that the tensile strength which will lead to failure of the sheath must be >15n.According to the results, the iso requirement as well as cmi's internal document requirement for the tensile force was fulfilled for both samples.The results of the destructive pull tests of the two subassembly lots which are related to the complaint lot were above the required limit: the ifu states the following: section warnings: "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." 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, none of these two points from ifu were followed: the dilator was not in place during the removal.There was a resistance during advancing of the sheath and they also tried to retract the sheath against the resistance.

• Brand Name: DURASHEATH INTRODUCER SHEATH SYSTEM
• Type of Device: INTRODUCER SHEATH
• Manufacturer (Section D): CONTRACT MEDICAL INTERNATIONL GMBH; lauensteiner strasse 37; dresden, germany 01277 , GM; GM 01277, GM
• MDR Report Key: 8260110
• MDR Text Key: 135162482
• Report Number: 3003637635-2019-00001
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• PMA/PMN Number: K181463
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 02/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/04/2021
• Device Model Number: FG-06090-002
• Device Catalogue Number: FG-06090
• Device Lot Number: 650933
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2019
• Date Manufacturer Received: 12/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 82 YR