MAUDE Adverse Event Report: CONTRACT MEDICAL INTERNATIONAL, GMBH DURASHEATH 6FR 450MM FINISHED GOOD; INTRODUCER SHEATH

Model Number FG-06045-002

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

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/15/2020

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.Manufacturer performed dhr review of the complaint lot 673497 and related subassembly lot 671553 of the sheath.No deviation was found.Manufacturing department / qc inspectors were informed about this complaint.

Event Description

The following description of the incident was reported through the complaint notification form: "during thrombosuction procedure sheath blocked and they could not retrieve it.Then it broke during firm retrieving and the braiding came all over the 0.035 wire as spiral.One part was left behind in the patient and went to the or." the patient had to went to the operational room where operator cut down of the groin.In the procedure was involved other medical device: jeti thrombosuction device.Additional information received by the distributor on 17.01.2020: "the vascular surgeon made a small cut in the groin and then the rest of the sheath came out very easy.Patient is doing well.The suction catheter was stocked in durasheath and everything has to come out in the hope to place a 7fr.Durasheath instead.".

Manufacturer Narrative

Manufacturer performed dhr review of the complaint lot 673497 and related subassembly lot 671553 of the sheath.No deviation was found.Manufacturing department / qc inspectors were informed about this complaint.The investigation was performed on the residue of the device that was returned by the distributor.For the investigation purposes, the returned sample was tested for the tensile force of the sheath.The sheath was initially put into the water bath (37°) for 2 hours to simulate the use in the patient.Destructive pull test was performed on two samples cut from the returned preconditioned device, with the following results: sample no.1: 20,55n (maximum load); sample no.2: 20,72 (maximum load).As described in iso 11070:2014, for the smallest outside diameter bigger or equal to 1,850 mm, the minimum required peak tensile force is 15n.Manufacturer's internal document technical specification (ts-00035-001) defines that the tensile strength which will lead to failure of the sheath must be bigger than 15n.The iso requirement as well as manufacturer's internal document requirement for the tensile force was fulfilled for both samples, despite the fact that on both samples were signs of elongation.The results of the 30 destructive pull tests of the subassembly lot which are related to the complaint lot were above the required limit with average values at the start of molding and the end of molding: 62,33 and 60,24.As mentioned at the beginning of this section, no qnrs were found in the records related to the complaint lot and related subassembly lot.Revision of trending of pull test results for sub-06045-002 from different lots was performed.Average values of the lots manufactured in 2019 were between 59,72n and 66,02n, which was well above 15n.The instructions for use, section precautions states the following: "do not attempt introducer sheath advancement or withdrawal without guide wire and dilator secured in place.Based on the information provided by the customer, the dilator was not in place during the removal.The suction catheter (jeti peripheral catheter) was stuck in durasheath.The minimum id of the guide sheath in which the device can be inserted is 0,087".The inner diameter of the durasheath system is 0,087".The tight fit between the jeti peripheral catheter and the durasheath could have led to the catheter being stuck in the durasheath and subsequent breakage of the durasheath.It is not clear from the information received from the distributor if the jeti device was also sent to the manufacturer for evaluation and what was the outcome of their investigation.The exact root cause could not be determined.Manufacturer's investigation did not reveal any design or manufacturing process related failure.

• Brand Name: DURASHEATH 6FR 450MM FINISHED GOOD
• Type of Device: INTRODUCER SHEATH
• Manufacturer (Section D): CONTRACT MEDICAL INTERNATIONAL, GMBH; lauensteiner strasse 37; dresden, 01277 ; GM 01277
• MDR Report Key: 9675210
• MDR Text Key: 220834563
• Report Number: 3003637635-2020-00001
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 04251244500160
• UDI-Public: 04251244500160
• 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: 03/05/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 10/17/2022
• Device Model Number: FG-06045-002
• Device Catalogue Number: FG-06045
• Device Lot Number: 673497
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2020
• Initial Date Manufacturer Received: 01/17/2020
• Initial Date FDA Received: 02/06/2020
• Supplement Dates Manufacturer Received: 01/17/2020
• Supplement Dates FDA Received: 03/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: REF. NO. WV6120-OUS, LOT NO. 1901022
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR