MAUDE Adverse Event Report: CONTRACT MEDICAL INTERNATIONAL, GMBH BIOTRONIK FORTRESS CROSSOVER INTRODUCER SHEATH, SINGLE PACKAGE, CURVED 45 CM, 6F

Model Number FG-06553-001A

Device Problems Entrapment of Device (1212); Difficult to Remove (1528); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/01/2020

Event Type  malfunction  

Manufacturer Narrative

The root cause of the incident is unknown at the time if the initial report.The complaint device was not returned to the manufacturer yet.Manufacturer performed dhr review of the complaint lot 666641 and related subassembly lots.No deviation was found in the records.Manufacturing department/qc inspectors were informed about this complaint.

Event Description

Following problem description was provided to cmi by the customer thru complaint notification form: "during retraction of the sheath, a material fracture occurred just behind the hemostatic valve.All parts of the sheath could be removed.The patient was not injured.".

Manufacturer Narrative

Manufacturer performed dhr review of the complaint lot 666641 and related subassembly lots.No deviation was found in the records.Manufacturing department / qc inspectors were informed about this complaint.The returned sample was sent for decontamination to the external laboratory prior to the investigation as described under sop-qa-012.After the decontamination, the product was inspected.The luer part is separated from the sheath as the sheath was pulled out of the luer and the line was deformed from a pull force.The luer itself was not damaged during the removal in the hospital.The surface of pebax extrusion seems intact.Detail of pulled sheath shows slightly molded surface from the molding process.The material is not joined with the luer itself.The process of molding was reviewed and all the data for this lot show a stable process.If this was a reason, this would be a single occurrence among the statistically stable and validated process controlled by spc pull test evaluation.The luer was cut to find out how deep was the sheath inserted.It was possible to insert the sheath back to the luer to simulate, how deep the sheath was inserted.According to the specification, the sheath part should be molded in the luer within 12 +/- 1 mm.The gap, how deep the sheath was inserted is 13 mm which is within the specification.The luer itself shows signs of spring winding however the walls are almost smooth, and it shows that the sheath was not fully joined with the luer as already stated above.Manufacturer tried to simulate the same defect samples of the same product part number (6f, 45cm, curved sheath) under even worse condition.It was produced: sheath molded in the depth of 12 mm, 6 mm and 4 mm under two different conditions: non-degreased and degreased.As described in iso 11070:2014, for the smallest outside diameter greater than or equal to 1, 850mm, the minimum peak tensile force is 15n.Manufacturer's internal document technical specification (b)(4) and customer's requirements document defines that the tensile strength which will leads to failure of the sheath must be > 35 n.All the parts even molded in the depth of half or 1/3 of the requirement passed the pull test.The iso requirement as well as manufacturer's internal / customer's document and requirements for the tensile force were fulfilled for all tested samples.There were 2 different lots of subcomponent used: lot 668446 and lot 669313.The results of the destructive pull tests of the all subassembly lots which are related to the complaint lot were above the required limit for in total 60 pcs.Subsequently trending of pull test results from 2019 was reviewed.The average value of the results from the start / end of the molding process was between 50 and 60n.The complaint lot passed 100% in-process inspections and aql based inspections performed by qc inspectors who are independent from production.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.Severe vascular damage and/ or injury may occur.Based on the information provided by the customer, a guide wire was in place during withdrawal but not a dilator.This is a contradiction with instructions for use / intended use.It is not possible to prove how big force was used by the doctor to pull out the sheath out of the body.Manufacturer concluded that the root cause is a combination of user error - not following the ifu - usage without dilator, not sure how big force the doctor used for withdrawal and eventually single occurrence of manufacturing related failure within a stable statistically robust process.

• Brand Name: BIOTRONIK FORTRESS CROSSOVER INTRODUCER SHEATH, SINGLE PACKAGE, CURVED 45 CM, 6F
• Type of Device: INTRODUCER SHEATH
• Manufacturer (Section D): CONTRACT MEDICAL INTERNATIONAL, GMBH; lauensteiner strasse 37; dresden, 01277 ; GM 01277
• MDR Report Key: 10319049
• MDR Text Key: 202424445
• Report Number: 3003637635-2020-00002
• 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: company representative
• Type of Report: Initial,Followup
• Report Date: 10/02/2020

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: 08/31/2022
• Device Model Number: FG-06553-001A
• Device Catalogue Number: 386593
• Device Lot Number: 666641
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/08/2020
• Initial Date FDA Received: 07/24/2020
• Supplement Dates Manufacturer Received: 07/08/2020
• Supplement Dates FDA Received: 10/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention