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

Catalog Number 68202081

Device Problems Unsealed Device Packaging (1444); Tear, Rip or Hole in Device Packaging (2385)

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

Event Date 02/20/2023

Event Type  malfunction  

Manufacturer Narrative

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 510 k number and pro code for the sleek rx pta catheter products are identified.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, a photo was provided for review.The investigation of the reported event is currently underway.(expiration date: 08/2024).Device pending return.

Event Description

It was reported that prior to an angioplasty procedure in the left carotid artery, the primary package of the balloon was allegedly found sealed incompletely, and there were no signs of tampering.It was further reported that the pouch packaging was allegedly not sealed.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 510 k number and pro code 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.Therefore, a device history record review is not required.Investigation summary: the device was returned for evaluation.A hooped clean litepac device was returned within its pouch.The pouch seal was open along the length of the lower end of the pouch.A continuous seal impression was present along the full length of the pouch indicating a seal operation has been performed.The device carton was not returned.Therefore, the result of the investigation is inconclusive for the reported pouch breach of sterility barrier issue.The root cause for the reported pouch breach of sterility barrier issue could not be determined based upon the available information received from the field communications and sample evaluation.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: ¿ visually inspect the packaging to verify that the sterile barrier is intact.Do not use if the sterile barrier is opened or damaged.H10: d4 (expiration date: 08/2024).

Event Description

It was reported that prior to an angioplasty procedure in the left carotid artery, the primary package of the balloon was allegedly found sealed incompletely and there were no signs of tampering.It was further reported that the pouch packaging was allegedly not sealed.The procedure was completed using another device.There was no patient contact.

• 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: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 16567988
• MDR Text Key: 311960718
• Report Number: 9616666-2023-00037
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 05391509837453
• UDI-Public: (01)05391509837453
• 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: 04/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 68202081
• Device Lot Number: CMFW0126
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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