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

Model Number 425-2022X

Device Problems Failure to Advance (2524); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

For the reported event, lot number was provided, and lot history review.The sample was returned for evaluation.There were 5 bends noted along the length of the shaft and a kink noted on the inner.The distal tip was slightly flattened from its midpoint to the point at the distal cone.It is unlikely that any of these issues contributed to the failure to advance issue reported.Therefore, failure to cross the lesion issue was inconclusive for the device.The device was labeled for single use.A root cause has not been determined.The device was labeled for single use.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.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model 425-2022x.Pta dilatation catheter allegedly experienced failure to advance and material deformation (kink).This report was received from a single source.This event did involve patient with no reported patient injury.The patients age, weight and gender were not provided.

• Brand Name: SLEEK RX PTA CATHETER
• Type of Device: PTA 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: judith ludwig ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 9182875
• MDR Text Key: 191036187
• Report Number: 9616666-2019-00112
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741132292
• UDI-Public: (01)00801741132292
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 425-2022X
• Device Catalogue Number: 425-2022X
• Device Lot Number: 50143539
• Date Manufacturer Received: 09/30/2019
• Type of Device Usage: Initial
• Patient Sequence Number: 1