MAUDE Adverse Event Report: CLEARSTREAM TECHNOLOGIES LTD. SAVVY LONG OTW PTA CATHETER; PTA BALLOON DILATATION CATHETER

Model Number 436-2522L

Device Problems Material Rupture (1546); Stretched (1601); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device was returned for evaluation.The investigation is unconfirmed for the alleged rupture, but confirmed for stretching and detachment.The root cause has not been determined.The device was labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model 436-2522l, pta balloon dilatation catheter, allegedly burst, stretched, and detached.This malfunction involved a patient with no consequences.The patient's age, weight, and gender were not provided.

• Brand Name: SAVVY LONG OTW 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: judith ludwig ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 9199599
• MDR Text Key: 194778246
• Report Number: 9616666-2019-00127
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741132865
• UDI-Public: (01)00801741132865
• 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: 10/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 436-2522L
• Device Catalogue Number: 436-2522L
• Device Lot Number: 50138146
• Date Manufacturer Received: 09/30/2019
• Type of Device Usage: Initial
• Patient Sequence Number: 1