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

Model Number 425-2515X

Device Problems Device Damaged Prior to Use (2284); Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)

Patient Problem No Patient Involvement (2645)

Event Date 10/24/2018

Event Type  malfunction  

Manufacturer Narrative

Manufacturing review: the lot number was provided and the lot device history records have been reviewed.The lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the reported failure mode 'device damaged prior to use' was confirmed during the investigation.The catheter was returned in two sections.There was a detachment noted at the proximal bond and outer and the inner was torn off at the re-port.Indents were observed on the sleeve and it could not be removed from the balloon during the evaluation.The shipping mandrel was returned within in the device.The definitive root cause for the reported issues could not be determined based upon available information.It is unlikely that these defects are manufacturing related.A 100% visual inspection for catheter defects is performed on devices during catheter production.The manufacturing documentation was reviewed and shows no anomalies with the manufacture of this lot to suggest a product issue.It is likely that handling or procedural techniques and excessive force during device preparation contributed to the reported event.Labeling review: ifu for sleek pta rapid exchange (rx) dilatation catheter product family was reviewed the following sections are applicable: 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.A 0.014¿ (0.356 mm) guidewire is recommended for use with the sleek® catheters.Warnings: 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: 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.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.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.(expiry date 03/2019).

Event Description

It was reported that during preparation, the pta balloon dilatation catheter was allegedly identified to be damaged.There was no reported patient involvement.

• Brand Name: SLEEK RX PTA DILATATION CATHETER
• Type of Device: PTA 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: judith ludwig ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 8227122
• MDR Text Key: 132995196
• Report Number: 9616666-2018-00188
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741132384
• UDI-Public: (01)00801741132384
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K072947
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 425-2515X
• Device Catalogue Number: 425-2515X
• Device Lot Number: CMBP0036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2017
• 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