MAUDE Adverse Event Report: CONTRACT MEDICAL INTERNATIONAL GMBH BIOTRONIK FORTRESS INTRODUCER SHEATH SYSTEM, 65CM 5F STRAIGHT

Model Number FG-05557-001

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

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

Event Date 06/01/2022

Event Type  Death  

Manufacturer Narrative

The root cause of the incident is unknown at the time of the initial report.The complained device has not been evaluated yet.The manufacturer performed dhr review of the complaint lot 686650 and subsequent sub-assemblies lots 688513, 677554 and 668589.No non-conformance, deviation or other abnormality relating to this event were found in the records.

Event Description

Dr (b)(6) used a fortress 5 x 65 sheath (item number: 444484, lot: 686650); as the introducing sheath was being removed for closure, dr (b)(6) realized the biotronik sheath frayed (was coming apart) inside the patient, which required double access in an attempt to snare, a quick decompensation of the patient which required a call to 911 and transfer to emergency room.This device has been saved for you for further investigation.Used a turbo laser 1.4 for the atherectomy.

Manufacturer Narrative

The manufacturer performed drh review of the complaint lot 686650 and subsequent lots 688513, 677554 and 668589 of the sheath.No non-conformance, deviation or other abnormality relating to this event were found in the records.The customer was asked for additional information needed for investigational purposes and provided following responses: 1.Q: what was the age of the patient and a reason for the treatment (intervention)? a: 54, pad w/ gangrene and threatened bypass.2.Q: was there any anatomical abnormality at the patient? a: no.3.Q: what was the calcification status of the treated vessel? a: not calcified.4.Q: what was patient condition before, during and after the treatment? a: h/o covid month prior, held anticoagulation (per noac recs) 48 hrs prior, condition stable prior, refer to nursing documentation for condition during and after treatment.Questions about the treatment and health care professional (hcp): 1.Q: what was the name of the procedure the hcp performed? a: angiogram w/ atherectomy/pta tibial.2.Q: was the initial procedure successful? a: yes.3.Q: how long was the device placed in the patient? a: 1.5 to 2.5 hrs.4.Q: did the hcp use the dilator when retrieving the device out of the patient body? a: amplatz wire only.5.Q: where did the separated piece of the device remain in the body? a: within right iliac crossing over into left iliac arteries.6.Q: is the hcp well-experienced with the use of fortress devices? a: yes, used for several years prior.7.Q: was there any other medical device involved in the procedure? a: yes, spectranetics 1.4mm laser, angioplasty balloons (biotronik), 014 command wire.The claimed device was received on 29-jun-2022.An analyse was started immediately.The complained device contained sheath, dilator, and haemostatic valve set.Guide wire is included in the delivery with the claimed device as well.In the package with the complained device was delivered also operative report from prima care p.C.This report includes details to the operative procedure in the hospital.Dimensions of the complained device were measured.Originally, the length is according to the drawing 650 ± 4 mm.The complained device is about 715 mm long.This elongation occurred due to plastic deformations by retrieving of the device with inappropriate force.Breakage area of the sheath is between 320-330 mm from the luer hub, but area of permanent plastic deformation goes through the whole structure of the sheath.The sheath structure shows marks of disproportionate load.A less damaged part of the complained sheath was selected and tested in strength.Strength test is a part of production testing as well.Strength test of claimed sample (2 samples cut out from the claimed part) is 32.2 and 35.86 n.Tested value is more than twice as high as required per the applicable standards, iso 10555-1 and iso 11070, which is 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.The customer biotronik/dr.R.P.Confirmed in questions to the treatment (see above), that the hcp did not use the dilator when retrieving the device out of the patient body.Only the amplatz wire was used.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.As the root cause was determined user error and not following of the ifu.The dilator was not used by retrieving the device out of the patient body.

• Brand Name: BIOTRONIK FORTRESS INTRODUCER SHEATH SYSTEM, 65CM 5F STRAIGHT
• Type of Device: INTRODUCER SHEATH
• Manufacturer (Section D): CONTRACT MEDICAL INTERNATIONAL GMBH; lauensteiner strasse 37; dresden, germany 01277 ; GM 01277
• Manufacturer (Section G): CONTRACT MEDICAL INTERNATIONAL GMBH; lauensteiner strasse 37; dresden, germany 01277 ; GM 01277
• Manufacturer Contact: juliana nuernberger ; lauensteiner strasse 37; dresden, germany 01277 ; GM 01277
• MDR Report Key: 14774472
• MDR Text Key: 294500653
• Report Number: 3003637635-2022-00002
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 04251244500573
• UDI-Public: 04251244500573
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153197
• 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: 06/22/2022

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: 02/29/2024
• Device Model Number: FG-05557-001
• Device Catalogue Number: 444484
• Device Lot Number: 686650
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/02/2022
• Initial Date FDA Received: 06/22/2022
• Supplement Dates Manufacturer Received: 06/02/2022
• Supplement Dates FDA Received: 09/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2021
• 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
• Treatment: 014 COMMAND WIRE; 014 SPARTA CORE WIRE; 03/05/90 CENTIMETER TRAILBLAZER CATHETER; 035 AMPLATZ WIRE; 1.4MM SPECTRANETICS LASER CATHETER; 2 MM BALLOON; 3MM BALLOON; 4F INTRODUCER; 5F INTRODUCER; 5F SHEATH; 6F INTRODUCER; BENSON WIRE; CHLORAPREP; HEPARIN; MICROPUNCTURE NEEDLE; OMNI FLUSH CATHETER; S-MAK MICROPUNCTURE CATHETER
• Patient Outcome(s): Death
• Patient Age: 54 YR