MAUDE Adverse Event Report: CLEARSTREAM TECHNOLOGIES LTD. SLEEK RX; PTA BALLOON DILATATION CATHETER

Catalog Number 425-2022X

Device Problems Material Separation (1562); Failure to Advance (2524); Physical Resistance (2578)

Patient Problems Calcium Deposits/Calcification (1758); Stenosis (2263)

Event Date 08/05/2016

Event Type  Injury  

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 device was returned.The investigation is currently in progress.Investigation is on-going.

Event Description

It was reported that the device could not be advanced and during removal the device separated.There were no anomalies noted during the prep of the device.There was no damage noted to the box, pouch, hoop or balloon sleeve and there was no difficulty removing the balloon sleeve.There were no kinks noted on the device prior to use.The target lesion was the left below knee.The lesion was moderately calcified and heavily tortuous.The rate of stenosis was 80%.Kbt was performed.A sleek device was advanced to the lesion with a 6f 90cm sheathless, asahi intecc guiding sheath.At the tortuous part of the iliac artery and the aorta bifurcation there was difficulty advancing the device.Therefore the device was retracted.However during removal there was resistance felt and the device separated.The complaint device was then advanced however as with the other sleek device used there was difficulty advancing the device and the device was removed.During removal there was resistance felt and the device separated.The separated part was out from the hub of the guiding sheath, and it was removed with using a biopsy forceps.It is unknown how many times the device was inserted into the patient and unknown if the device was ever inflated.It is unknown if force was required and unknown if kinks were noted during or after use.All parts of the device were removed from the patient.It is unknown how the procedure was completed but the procedure was finished successfully.There was no patient injury reported.

Manufacturer Narrative

It was reported that the device could not be advanced and during removal, the device separated.There were no anomalies noted during the prep of the device.There was no damage noted to the box, pouch, hoop or balloon sleeve and there was no difficulty removing the balloon sleeve.There were no kinks noted on the device prior to use.The target lesion was the left below knee.The lesion was moderately calcified and heavily tortuous.The rate of stenosis was 80%.Kbt was performed.A sleek device was advanced to the lesion with a 6f 90cm sheathless, asahi intecc guiding sheath.At the tortuous part of the iliac artery and the aorta bifurcation there was difficulty advancing the device.Therefore the device was retracted.However during removal there was resistance felt and the device separated.The complaint device was then advanced however as with the other sleek device used there was difficulty advancing the device and the device was removed.During removal, there was resistance felt and the device separated.The separated part was out from the hub of the guiding sheath, and it was removed with using a biopsy forceps.It is unknown how many times the device was inserted into the patient and unknown if the device was ever inflated.It is unknown if force was required and unknown if kinks were noted during or after use.All parts of the device were removed from the patient.It is unknown how the procedure was completed but the procedure was finished successfully.There was no patient injury reported.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 and issue to date.The device was returned for evaluation.The device was visually inspected under 4x-60x magnification by digital microscope camera.No external or internal packing was returned.The device was returned in two pieces.The first piece measured 220mm from the strain relief and the second piece measured 131mm.The hub was printed as expected and no visual defects were observed.The hypotube was returned in two pieces.There were a total of eight kinks noted between the two separate pieces.On piece one, there were two kinks noted.The first severe kink was noted approx.85mm from the strain relief and the second kink was noted approx.200mm from the strain relief.The break on this piece is jagged and is slightly flattened and not circular in shape.On piece two three kinks noted.The first slight kink was noted approx.15mm from the proximal side; the second severe kink was noted approx.20mm from the proximal markerband and the third kink was noted approx.240mm from distal markerband.A fourth kink was noted approx.65mm from the re-port on the transition outer.No visual defects observed on the re-port, outer or balloon.Four more kinks were noted on the inner.The first was just at the bond, the second was 60mm from the proximal markerband , the third kink was noted approx.110mm from the proximal markerband and fourth kink was noted approx.5mm from the distal markerband.The middle of the distal tip is flattened.No functional examination carried out on the device as not applicable to the complaint.The result of the investigation is confirmed.Based upon the available information a definitive root cause has not been determined.It is unknown whether patient factors, such as the reported 80% stenosis, handling or procedural techniques have contributed to the reported event.Based on trending analysis performed no additional action is required at this time.The ifu states: description: the sleek® percutaneous transluminal angioplasty (pta) peripheral catheter.Family comprise a range of sizes of rapid exchange catheters for peripheral angioplasty.The catheter¿s proximal tubing is 304v stainless steel and the distal coaxial tubings are nylon co-polymer blend.The lumen of the shaft is used for the purpose of inflating and deflating the balloon.A second lumen at the tip is used for advancing the guidewire.Indications: the sleek® catheters are intended for balloon dilatation of the femoral, popliteal and infra-popliteal arteries.These catheters are not designed to be used in the coronary arteries.Warnings: 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.Precautions: carefully inspect the catheter prior to use to verify that the catheter has not been damaged during shipment and that its size, shape and condition are suitable for the procedure for which it is to be used.Do not use if product damage is evident.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.If the hypotube kinks prior to or during use the catheter should be discarded.No attempt should be made to straighten a kink in the hypotube.Storage: store in a cool, dark, dry place.Use the catheter prior to the ¿use by¿ date specified on the package.Directions for use: inspection and preparation remove the balloon sleeve by first withdrawing the shipping mandrel slightly and then slowly removing the sleeve while holding the catheter as close to the balloon as possible.If any resistance is felt, or if any stretching of the catheter is observed while removing the balloon sleeve, the product should not be used.The catheter should then be inspected for bends, kinks or stretched portions.Do not use if product damage is evident.Deflation and withdrawal simultaneously withdraw the dilatation catheter and guidewire from the guiding catheter/sheath.As the balloon exits the vessel, use a smooth, gentle, steady, motion.If resistance is felt upon removal then the balloon, guidewire and the guiding catheter/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 guiding catheter/sheath as a unit and withdrawing both together, using a gentle twisting motion combined with traction.(b)(4).

• Brand Name: SLEEK RX
• Type of Device: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford ; EI
• Manufacturer (Section G): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford ; EI
• Manufacturer Contact: fiona nimhullain ; 539237111
• MDR Report Key: 5932953
• MDR Text Key: 54082145
• Report Number: 9616666-2016-00024
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• PMA/PMN Number: K072947
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Catalogue Number: 425-2022X
• Device Lot Number: 50121528
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 08/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2016
• 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