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

Catalog Number 68202149

Device Problems Break (1069); Stretched (1601); Detachment of Device or Device Component (2907); Material Deformation (2976)

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

Event Date 12/08/2021

Event Type  malfunction  

Event Description

It was reported that during preparation for a catheter placement procedure, the balloon of the device allegedly detached during removal of the protective cover.The procedure was completed using another device.There was no patient contact.

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history record is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.The catalog number identified has not been cleared in the us but is similar to the sleek rx pta catheter products that are cleared in the us.The pro code and 510 k number for the sleek rx pta catheter products are identified in common device name and pma/510k.(expiry date: 09/2023).

Event Description

It was reported that during preparation for a catheter placement procedure, the balloon of the device allegedly detached during removal of the protective cover.The procedure was completed using another device.There was no patient contact.

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the sleek rx pta catheter products that are cleared in the us.The pro code and 510 k number for the sleek rx pta catheter products are identified in d2 and g4.H10: manufacturing review: a complaint history review was performed.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 returned for evaluation.The balloon was detached from the outer at the proximal bond.A break in the inner was confirmed at the re-port and was stretched for a length of 122mm in the exposed section of the balloon and the outer detachment.The sleeve was not returned.The result of the investigation is confirmed for the reported balloon detachment issue.The root cause for the reported balloon detachment issue could not be determined based upon the available information.However the balloon detachment and the stretched and broken inner suggest that handling techniques (excessive force) was responsible for this damage, likely occurring during the attempted sleeve removal during device preparation.Labeling review: the instructions for use for the litepac rx pta catheter was reviewed and contains the following information relevant to the reported event: warnings: precautions: ¿ carefully inspect the catheter prior to use to verify that 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.Do not continue to use the balloon catheter if the shaft has been bent or kinked.Directions for use: inspection and preparation: ¿ remove the protective sheath by first withdrawing the stylet and then slowly removing the sheath 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 protective sheath, 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.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.

• Brand Name: LITEPAC RX 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
• Manufacturer (Section G): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford N A ; EI N A
• Manufacturer Contact: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 13175964
• MDR Text Key: 286563008
• Report Number: 9616666-2021-00248
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 05391515540804
• UDI-Public: (01)05391515540804
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: K072947
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 68202149
• Device Lot Number: CMEX0161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2020
• 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