MAUDE Adverse Event Report: CONTRACT MEDICAL INTERNATIONL GMBH BIOTRONIK FORTRESS INTRODUCER SHEATH SYSTEM, 45CM 6F STRAIGHT

Model Number FG-06551-001A

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/11/2019

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 the evaluation has not begun yet.The dhr review of the complaint lot 648399 and related subassembly lots 647857, 647856 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 inspections.The manufacturer informed manufacturing operators and qc inspectors about the complaint.No remedial actions were initiated at the time of the initial report, since the exact root cause was not determined yet.

Event Description

The doctor said that the patient had previous surgery to the groin so there was some scarring but no calcification and a vein patch to the artery.He used an ultrasound to puncture the artery at the site of the venous patch.There was slight resistance when he swapped the short sheath for the 6f 45cm fortress but was not concerned by this.Once he went to remove the sheath he felt more resistance and could see that the sheath was elongating.At this point he inserted the dilator and swapped to a stiff lunderquist wire (cook)to offer more support.Unfortunately this did not stop the sheath from elongating further and snapping into 2 parts.He needed to cut down into the groin superficially where he was able to locate the distal portion of the sheath and remove it.He was able to suture the femoral puncture and oversew the small incision in the skin.

Manufacturer Narrative

The dhr review of the complaint lot 648399 and related subassembly lots 647857 and 647856 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 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: the customer provided to cmi additional information, that the doctor felt a slight resistance when he swapped the short sheath for the 6f 45cm fortress, but he was not concerned by this.Before starting to withdraw the sheath, the doctor had the dilator and stiff guidewire in place.He felt more resistance during the removal of the sheath, and could see that the sheath was elongating.Although the dilator was in place, further elongating of the sheath did not stop and sheath snapped into two parts.For the investigation purposes, the returned device was tested for the tensile force of the sheath.The sheath was initially put into the water bath (37°c) for two hours to simulate the use in the patient.Subsequently, the destructive pull tests were performed on nine 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.Cmi's internal document technical specification and customer's requirements document defines that the tensile strength which leads to failure of the sheath must be >35n.According to the results, the iso requirement as well as cmi's internal/customer's requirements, for the tensile force were fulfilled for all six samples which were taken from the part of the sheath which was not deformed.The other three samples taken from the deformed part had a lower tensile force, which is caused by the sheath elongation and subsequent decrease of the mechanical durability of the sheath.Instructions for use, section warnings states: "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." root cause: the root cause is unknown, could not be determined.

• Brand Name: BIOTRONIK FORTRESS INTRODUCER SHEATH SYSTEM, 45CM 6F STRAIGHT
• Type of Device: INTRODUCER SHEATH
• Manufacturer (Section D): CONTRACT MEDICAL INTERNATIONL GMBH; lauensteiner strasse 37; dresden, germany 01277 ; GM 01277
• MDR Report Key: 8331224
• MDR Text Key: 137416964
• Report Number: 3003637635-2019-00003
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 04251244500078
• UDI-Public: 04251244500078
• Combination Product (y/n): N
• PMA/PMN Number: K153197
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/29/2019

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: 02/28/2021
• Device Model Number: FG-06551-001A
• Device Catalogue Number: 386594
• Device Lot Number: 648399
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2019
• Initial Date Manufacturer Received: 01/22/2019
• Initial Date FDA Received: 02/12/2019
• Supplement Dates Manufacturer Received: 01/22/2019
• Supplement Dates FDA Received: 04/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other