MAUDE Adverse Event Report: CLEARSTREAM TECHNOLOGIES, LTD. SLEEK OTW

Catalog Number 426-2015X

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/17/2015

Event Type  Injury  

Event Description

It was reported that the shaft separated when attempting to remove the device from the pt.During an angiography procedure, the device was used to gain reentry into the right common iliac artery.The device was used to dilate the right common and external iliac artery.The lesion was successfully dilated without issue.However, when attempting to remove the device there was difficulty removing over the guidewire.The physician pulled very hard in order to attempt to remove the device and the shaft separated.In order to continue with the procedure the guidewire had to be cut to remove the remainder of the device to allow a catheter to go over the guidewire.It was reported that when the device was initially being advanced over the guidewire it was observed to be very tight and tracking over the guidewire was not very smooth.At this time the physician did not feel it was an issue.Reportedly the device was not kinked at any time throughout the procedure.There was a procedural delay of ten minutes as a result of the failure.There was no pt injury reported.

Manufacturer Narrative

Receipt of device is pending.The investigation is currently in progress.

Manufacturer Narrative

The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.The lot history records have been reviewed with special attention to the manufacturing and inspection of this product.The device was found to have met specifications prior to shipment.No manufacturing anomalies were identified that may have caused or contributed to the reported event.This is the first event reported for this lot number to date.The device was returned for evaluation.Evaluation of the returned sample identified that there was no external or internal packaging returned and no visual defects were noted on the hub of the device.The inner has separated inside the outer and the inner is also bunched on the guidewire inside the balloon.The outer is kinked 7cm away from the proximal bond.The balloon is bunched and there was damage noted to the distal tip.The complaint guidewire was returned.The guidewire is in two pieces and 6 kinks were noted on the guidewire.The guidewire is also coiled where separation occurred.There was damage noted to the guidewire and the blue coating has also been peeled off on small parts of the guidewire.The result of the investigation is confirmed.It was reported that the shaft separated when attempting to remove the device from the patient.Evaluation of the device confirms that the device is in two pieces.It was reported that force was used to remove the device, causing the shaft to separate.It is also possible that the kinks noted on the guidewire during evaluation and the peeling of the blue coating on the guidewire may have contributed to the issue of the device becoming difficult to remove over the guidewire as reported.The ifu states: "the sleek® otw catheters are intended for balloon dilatation of the femoral, popliteal and infra-popliteal arteries." in this incident the target were the right common and external iliac artery.Precautions bullet point 4 states 'if resistance is felt upon removal, then the balloon, guidewire and the sheath/guide catheter should be removed together as a single unit.' in this incident force was used in an attempt to remove the device while leaving the guidewire access in place.Warnings bullet point 8 states: "do not advance the guidewire, balloon dilation catheter, or any component if resistance is met".As reported in this incident "advanced over the guidewire it was observed to be very tight and tracking over the guidewire was not very smooth" from the reported incident it is unclear is the cause of the resistance was determined and if any remedial action was taken it is reported that the "physician pulled the device very hard in order to attempt to remove the device and the shaft separated" this is against ifu guidelines and may have directly contributed to the reported event.However, based upon the available information a definitive root cause cannot be determined.Based on trending analysis performed no additional action is required at this time.The ifu states: warnings: ¿ do not exceed the rated burst pressure.A syringe with pressure gauge is recommended to monitor pressure.Pressure in excess of the rated burst pressure can cause balloon rupture and potential inability to withdraw the catheter through the introducer sheath.¿ reuse, resterilization, reprocessing and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient.¿ use the catheter prior to the ¿use by¿ date specified on the package.¿ do not advance the guidewire, balloon dilation catheter, or any component if resistance is met, without first determining the cause and taking remedial action.Precautions: ¿ if resistance is felt upon removal, then the balloon, guidewire and the sheath/guide catheter should be removed together as a unit, particularly if balloon rupture or leakage is known or suspected.This may be accomplished by firmly grasping the balloon catheter and sheath/guide catheter as a unit and withdrawing both together, using a gently twisting motion combined with traction.¿ before removing catheter from sheath/guide catheter it is very important that the balloon is completely deflated.¿ proper functioning of the catheter depends on its integrity.Care should be used when handling the catheter.Damage may result from kinking, stretching, or forceful wiping of the catheter.Directions for use: inspection and preparation ¿ the catheter should then be inspected for bends, kinks or stretched portions.Do not use if product damage is evident.¿ prepare a mixture of contrast medium and normal saline as per normal procedure.(recommended 25%/75%) procedure: insertion and inflation procedure: note: a 0.014¿ (0.356 mm) guidewire must be inserted in the sleek® otw catheter across the balloon during any inflation of the balloon.Make sure that the balloon sleeve has been removed from the catheter balloon.Enter the vessel percutaneously using the standard seldinger technique over the appropriate guidewire for the size catheter being used.Advance the catheter across the lesion with fluoroscopic guidance using accepted percutaneous transluminal angioplasty technique and inflate the balloon to the appropriate pressure.Note: do not inflate the balloon or advance the catheter unless the guidewire is in place.Deflation and withdrawal ¿ deflate the balloon by drawing a vacuum with a 20 ml or larger syringe.Note: the larger the syringe diameter, the greater the suction that is applied.For maximum deflation a 50 ml syringe is recommended.¿ gently withdraw the catheter.As the balloon exits the vessel, use a smooth, gentle, steady, counterclockwise motion.If resistance is felt upon removal then the balloon and the sheath should be removed together as a unit under fluoroscopic guidance, particularly if balloon rupture or leakage is known or suspected.This may be accomplished by firmly grasping the balloon catheter and sheath as a unit and withdrawing both together, using a gentle twisting motion combined with traction.(b)(4).

Event Description

It was reported that the shaft separated when attempting to remove the device from the patient.There were no anomalies noted during the prep of the device.There was no damage noted to the box, pouch, hoop or balloon sleeve.There was no difficulty removing the device from the hoop and no difficulty removing the balloon sleeve or stylet.The device was stored, handled and prepped according to the ifu.During an angioplasty procedure the device was used to gain reentry into the right common iliac artery.There was occlusion of the right common iliac.The device was used to dilate the right common and external iliac artery.The lesion was successfully dilated without issue.However, when attempting to remove the device there was difficulty removing over the guidewire.The device and guidewire were not attempted to be removed together as the physician would have lost guidewire access.The physician pulled the device very hard in order to attempt to remove the device and the shaft separated.When the device separated it was outside the patient.In order to continue with the procedure the guidewire had to be cut to remove the remainder of the complaint device to allow a catheter to go over the guidewire.It was reported that when the device was initially being advanced over the guidewire it was observed to be very tight and tracking over the guidewire was not very smooth.At this time the physician did not feel it was an issue.Reportedly the device was not kinked at any time throughout the procedure.The device was inserted into the patient once and was inflated 2 to 3 times.There was a procedural delay of ten minutes as a result of the failure.There was no patient injury reported.

• Brand Name: SLEEK OTW
• Manufacturer (Section D): CLEARSTREAM TECHNOLOGIES, LTD.; enniscorthy, o. wexford ; EI
• Manufacturer (Section G): CLEARSTREAM TECHNOLOGIES, LTD.; moyne upper ; enniscorthy, co., wexford ; EI
• Manufacturer Contact: fiona nimhullain ; moyne upper ; enniscorthy co., wexford ; EI ; 539237111
• MDR Report Key: 4792284
• MDR Text Key: 5813972
• Report Number: 9616666-2015-00001
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K102035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor,distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2017
• Device Catalogue Number: 426-2015X
• Device Lot Number: 50116375
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2014
• 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
• Patient Outcome(s): Required Intervention