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

Catalog Number 68202087

Device Problems Inflation Problem (1310); Failure to Advance (2524)

Patient Problems Infiltration into Tissue (1931); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/01/2021

Event Type  Injury  

Event Description

It was reported that during a stent implantation procedure in carotid artery, the syringe allegedly could not enter into the tip of the balloon.It was further reported that infiltration occurred during external flushing of the balloon.The procedure was completed by using another device.The current status of the patient was unknown.

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 not been returned to the manufacturer for evaluation.However, a photo was provided for review.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.(expiry date: 05/2024) device not returned.

Event Description

It was reported that during a procedure in a severely calcified carotid artery the balloon was allegedly could not be inflated.The procedure was completed by using another device.The current status of the patient was unknown.

Manufacturer Narrative

H10: the file was reassessed for reportability and determined to be no longer reportable.Since an initial mdr was submitted, therefore, the file will remain assessed as a serious injury.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: (expiry date: 05/2024).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.

• 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: 12915596
• MDR Text Key: 286128560
• Report Number: 9616666-2021-00219
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 05391509837514
• UDI-Public: (01)05391509837514
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 02/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 68202087
• Device Lot Number: CMFT0145
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other
• Patient Age: 56 YR
• Patient Sex: Male