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

Model Number FG-04551-002

Device Problems Entrapment of Device (1212); Difficult to Remove (1528); Material Separation (1562); Material Deformation (2976)

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

Event Date 10/14/2020

Event Type  malfunction  

Manufacturer Narrative

The root cause of the incident is unknown at the time of the initial report.The complaint device is expected to be returned to the manufacturer.Manufacturer performed dhr review of the complaint lot 643704, and related sub-assemblies lots.There was found no qnr, or deviation, which could contribute to the reported incident.Manufacturing department / qc inspectors were informed about this complaint.The customer confirmed that there was no dilator in place during removal.This would mean contradiction with instructions for use.

Event Description

Following problem description was provided to cmi by the customer, "the catheter came apart during removal.It was said there was scar tissue at bifurcation.0.35 wire was in catheter during removal." "the fortress was pinched and came apart after that crease.A crossing catheter was placed over the wire and the fortress was able to be removed from the body.The fortress flushed properly before entering the body and the integrity seemed normal." name of procedure: angio l leg with atherectomy (boston scientific rotablator 1.25) and balloon angioplasty; treated vessel: distal sfa.

Manufacturer Narrative

Manufacturer performed dhr review of the complaint lot 643704 and related subassemblies lots.There was found no qnr or deviation which could contribute to the reported incident.Manufacturing department / qc inspectors were informed about this complaint.It was reported by the customer that there were other medical devices involved in the incident: boston scientific rotablator 1.25 and cxi® support catheter 4fr.035'' 90 cm from the manufacturer cook medical.The cook catheter was returned with the complaint biotronik device.The samples were sent for decontamination to the external laboratory as described in sop-qa-012.After the decontamination, the samples were inspected.The cook cxi® support catheter was inserted in the sheath.The cook catheter was pressed into the sheath so tightly that was not possible to pull out the cook catheter out of the sheath.The sheath was broken approximately 8 cm behind haemostatic valve.The whole integrity of the sheath was damaged most likely caused during removal.Before start of investigation the customer was asked by manufacturer for additional information with following questions: 1) was there any problem during advancing? 2) was there felt any resistance during advancing / removal? 3) was the dilator in place during removal? the customer representative answered that there was a resistance during advancing - the physician believes that there was scar tissue at the bifurcation.The dilator was not in place during removal.Instead the cook crossing catheter was placed in the sheath for support.For the investigation purposes, the returned biotronik device was tested for the tensile force of the sheath.The sheath was initially put into the water bath (37°c) for 2 hours to simulate the use in the patient.Subsequently, the destructive pull tests were performed on 5 samples cut from the returned device, with the following results: 10.93n (sample from place behind haemostatic valve), 11.60n (sample from 4cm from marker band), 13.74n (sample from 3cm from marker band), 16.77n (sample from 2cm from marker band), 15.92n (sample from 1cm from marker band).As described in iso 11070:2014, for the smallest outside diameter bigger or equal 1,850mm, the minimum peak tensile force is 15n however according manufacturer's internal document technical specification ts-00160-001 manufacturer uses safety factor 1.5 agreed with the customer so the testing limit is 22.5n.The iso requirement was fulfilled only for two samples from the returned device.Manufacturer's internal / customer's requirement for the tensile force was not met in any of the samples.The results are affected by the damaged integrity of the sheath caused during the procedure.The results of the destructive pull tests of the subassembly sheath lots 644467 and 646416 which are related to the complaint lot were above the required limit.Manufacturer subsequently checked a trending of all sheaths produced in the same year as the complaint lots (which is year 2018).Average value of pull test results is around 42n.As the second step within the investigation of the complaint sample was check of the passthrough of the haemostatic valve.There was no issue observed.The instructions for use, 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." based on the information provided by the customer, there was a resistance felt during advancing - the physician believes that there was scar tissue at the bifurcation.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 from the customer, there was no dilator present during removal.The cook crossing catheter was placed in the sheath for support instead.Based on the complaint investigation, there is no indication that the incident was caused by manufacturer's design or manufacturing process failure.After considering all available information provided by customer and information from the complaint investigation, the most likely root cause is end user error - there was no dilator present as required by instructions for use.

• 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
• MDR Report Key: 10807695
• MDR Text Key: 215301958
• Report Number: 3003637635-2020-00004
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 04251244500016
• UDI-Public: 04251244500016
• Combination Product (y/n): N
• PMA/PMN Number: K100799
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 12/17/2020

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: 03/31/2021
• Device Model Number: FG-04551-002
• Device Catalogue Number: 358814
• Device Lot Number: 643704
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2020
• Initial Date Manufacturer Received: 10/21/2020
• Initial Date FDA Received: 11/09/2020
• Supplement Dates Manufacturer Received: 10/21/2020
• Supplement Dates FDA Received: 12/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other