MAUDE Adverse Event Report: CONTRACT MEDICAL INTERNATIONAL GMBH BIOTRONIK 6F, CROSSOVER, 45 CM; INTRODUCER SHEATH, PRODUCT CODE: DYB

Model Number FG-06553-001A

Device Problems Entrapment of Device (1212); Difficult to Remove (1528); Material Deformation (2976)

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

Event Date 02/01/2021

Event Type  malfunction  

Manufacturer Narrative

The root cause of the incident is unknown at the time of the initial report.The complaint device is not expected to be returned to the manufacturer.The manufacturer cannot perform dhr review since the lot number was not provided.Actual production and inspection data were reviewed - no non-conformity has been found.

Event Description

Following problem description was provided to cmi by the medwatch 3500a form 4100070000-2021-8011: towards end of angiogram, surgeon had difficulty removing 6fr fortress sheath from patient´s right femoral artery.New dilator given per surgeon request.Surgeon able to remove sheath.Sheath appeared to have damage to outside material, a malfunction.X-ray tech notified.Surgeon states all parts from damaged sheath accounted for.No sheath parts left in patient.Damaged sheath w/dilator was placed in biohazardous bag along with 2nd sheath that was opened.Defective device given to x-ray tech.The end user described the problem as: device malfunction - that is, the device did not do what it was supposed to do.

Manufacturer Narrative

Although the lot number has not been reported, the manufacturer performed the dhr review for all lots distributed to the same hospital in last three (3) years which is the device shelf life.No deviation was found in the dhr records of the lot numbers 644277, 652618, 658865, 669298 and 670825.The manufacturer could not perform the investigation of the complaint sample since the device was discarded in the hospital.Very limited information about the event was provided through medwatch form.The failure mode is described as malfunction - damage to outside material, but it is not specified in detail what concretely happened with the device.As per the description, the surgeon felt the resistance when pulling the sheath out of the patient.It is not known, if some resistance was also felt during the device introduction or the procedure.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 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.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 on representative quantity of the samples.The trending data confirms the process is stable and capable to produce conform devices.Based on the complaint investigation, there is no indication that the incident was caused by the manufacturer´s design or manufacturing process failure.After considering of all available information the most likely root cause relates to the user when not following the instructions for use during the removal of the device.

• Brand Name: BIOTRONIK 6F, CROSSOVER, 45 CM
• Type of Device: INTRODUCER SHEATH, PRODUCT CODE: DYB
• Manufacturer (Section D): CONTRACT MEDICAL INTERNATIONAL GMBH; lauensteiner strasse 37; dresden, 01277 ; GM 01277
• MDR Report Key: 11639879
• MDR Text Key: 244627284
• Report Number: 3003637635-2021-00002
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 04251244500092
• UDI-Public: 04251244500092
• Combination Product (y/n): N
• PMA/PMN Number: K153197
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 07/21/2021

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 Model Number: FG-06553-001A
• Device Catalogue Number: 386593
• Device Lot Number: NOT REPORTED
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/25/2021
• Initial Date FDA Received: 04/09/2021
• Supplement Dates Manufacturer Received: 03/25/2021
• Supplement Dates FDA Received: 07/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR