MAUDE Adverse Event Report: CONTRACT MEDICAL INTERNATIONAL GMBH BIOTRONIK 4F, STRAIGHT 45 CM, INTRODUCER SHEATH, MULTIPACK

Model Number FG-04551-002

Device Problems Difficult to Remove (1528); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/27/2021

Event Type  malfunction  

Manufacturer Narrative

Cmi performed dhr review of the complaint lot 675761 and subsequent lots 675763 and 678579 of the sheath.No qnr, deviation or other abnormality relating to this event were found in the records.According to the complaint description and the results of previous complaints investigations, there is no indication that the incident is related to the manufacturing process failure.Therefore, there is no need to inform manufacturing department / qc inspectors at the time of this report.

Event Description

The customer reported: the sheath came apart inside patient.The sheath was retrieved with an auryon catheter.No patient injury had occurred verified by x-ray.Treated vessel: right sfa (superficial femoral artery), reference diameter 4mm, stenosis degree: 50%, vessel tortuosity: moderate, calcification: mild.Pre-dilatation: no.Final patient´s outcome: discharged home.

Manufacturer Narrative

Cmi performed dhr review of the complaint lot 675761 and subsequent lots 675763 and 678579 of the sheath.No non-conformance, deviation or other abnormality relating to this event were found in the records.According to the complaint description and the results of previous complaints investigations, there is no indication that the incident is related to the manufacturing process failure.The claimed device was received on 10-mar-2022.An analyse was started immediately.Visual control was performed.The introducer sheath was returned incomplete - without dilator.Significant defects were detected.The introducer sheath outer and inner tubes are disrupted in 4 parts.The sheath is deformed most probably by a chirurgical tool.Stainless steel coil is apart, which shows the use of enormous force for removing.Tip of the sheath is not deformed.An undamaged part of the complained sheath was selected and tested in strength.Strength test is a part of production testing as well.Acceptance criterium is thereby f equal or higher than 22.5 n.This criterium was according the dhr review during the production fulfilled (min.33.30 n and max.42.6 n).Strength test of claimed sample (cut out from the claimed part) is 41.08 n which is more than twice as high as required per the applicable standards, iso 10555-1 and iso 11070, which requires 15 n.Applicable instructions for use (ifu) in 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.In section precaution of the ifu is specified: · 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 initial information that the event happened during the end of the angiogram we conclude the device was fully functional during the procedure and the malfunction appeared during the device retrieval.The ifu in section removal instructs the health care professional how to properly retrieve the device: 1.Insert the dilator over the guide wire and fully into the introducer sheath.2.The introducer sheath may be removed when clinically indicated.Compression on the vessel above the puncture site should be started as the introducer sheath is slowly removed.Note: collected fibrin at the tip of the introducer sheath may be aspirated via the side arm tubing prior to removal of the introducer sheath.3.Discard the introducer sheath appropriately.4.Upon removal of the introducer sheath, precautions should be taken to prevent bleeding, vessel damage, or other serious injury.The use of the dilator during the device removal is essential to prevent the device and the vascular damage.It is unknown if the dilator was in place during the device removal or not.Dilator was not present in the returned delivery.Each lot of the finished goods and the subassemblies is manufactured in accordance with the routings specified in working instructions (mpp).There is also a system of inspections that verifies the conform products are released on the market.As part of the inspections, each lot of the sheaths is being pull tested (strength test) on representative quantity of the samples.The trending data confirms the process is stable and capable to produce conform devices.The analysis of the claimed part results using of disproportionate force.Based on the review of all available information the root cause most likely relates to the user, when not following of the instructions for use during the removal of the device which lead to its destruction.

• Brand Name: BIOTRONIK 4F, STRAIGHT 45 CM, INTRODUCER SHEATH, MULTIPACK
• Type of Device: INTRODUCER SHEATH
• Manufacturer (Section D): CONTRACT MEDICAL INTERNATIONAL GMBH; lauensteiner strasse 37; dresden, 01277 ; GM 01277
• Manufacturer (Section G): CONTRACT MEDICAL INTERNATIONAL GMBH; lauensteiner strasse 37; dresden, 01277 ; GM 01277
• Manufacturer Contact: juliana vaz nuernberger ; lauensteiner strasse 37; dresden, 01277 ; GM 01277
• MDR Report Key: 13278750
• MDR Text Key: 295320177
• Report Number: 3003637635-2022-00001
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 04251244500016
• UDI-Public: 04251244500016
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100799
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: FG-04551-002
• Device Catalogue Number: 358814
• Device Lot Number: 675761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/14/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Sex: Male