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

Model Number 426-5028X

Device Problems Inflation Problem (1310); Retraction Problem (1536); Material Rupture (1546); Improper or Incorrect Procedure or Method (2017); Detachment of Device or Device Component (2907); Material Twisted/Bent (2981)

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

Event Date 05/01/2021

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.However, photos were provided for review.The investigation of the reported event is currently underway.(expiry date: 04/2021).

Event Description

It was reported that during an angioplasty procedure the balloon allegedly twisted.It was further reported that the balloon ruptured during the procedure.Reportedly the device also had a retraction issue and the balloon was allegedly broken.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: the complaint history review, this is the first complaint reported for this product/lot number combination.However, the device history records were reviewed and there was nothing found to indicate there was a manufacturing related cause for these reports.Investigation summary: the sample was not returned for evaluation.The result of the investigation is confirmed for the reported balloon twist, rupture and break issue.An image provided for review showed a bloody balloon with full circumferential rupture.Two other fluoroscopy images indicated a balloon twist.The result of the investigation is inconclusive for the reported device retraction issue.The root cause for issues could not be determined based upon the available information received from the field communications and images reviews.Labeling review: the ifu for the sleek otw product was reviewed and contains the following information relevant to the reported event: warnings: use the catheter prior to the ¿use by¿ date specified on the package.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.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.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.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.Indications: the sleek® otw 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.H10: d4 (expiry date: 04/2021).H11:section a through f - the information provided by bd 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 bd.H3 other text : device not returned.

Event Description

It was reported that during an angioplasty procedure the balloon allegedly twisted.It was further reported that the balloon ruptured during the procedure.Reportedly the device also had a retraction issue and the balloon was allegedly broken.There was no reported patient injury.

• Brand Name: SLEEK OTW PTA CATHETER
• Type of Device: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford N A ; EI N A
• MDR Report Key: 11893012
• MDR Text Key: 252966642
• Report Number: 9616666-2021-00084
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741134036
• UDI-Public: (01)00801741134036
• Combination Product (y/n): N
• PMA/PMN Number: K130786
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/08/2021

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 Model Number: 426-5028X
• Device Catalogue Number: 426-5028X
• Device Lot Number: CMCS0447
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/04/2021
• Initial Date FDA Received: 05/27/2021
• Supplement Dates Manufacturer Received: 07/15/2021
• Supplement Dates FDA Received: 07/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other