MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR (BPV) CATERPILLAR EMBOLIZATION SYSTEM

Model Number CTP027015U

Device Problem Material Perforation (2205)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a lot history review was performed.The sample was not returned to the manufacturer for evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The device is labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model ctp027015u embolization system allegedly experienced material perforation.This information was received from one source.The malfunction had patient involvement but the patient had no consequences.The patient's age, weight, and gender were not provided.

• Brand Name: CATERPILLAR EMBOLIZATION SYSTEM
• Type of Device: EMBOLIZATION
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR (BPV)
• 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: 10283321
• MDR Text Key: 201721262
• Report Number: 9616666-2020-00071
• Device Sequence Number: 1
• Product Code: KCT
• UDI-Device Identifier: 00801741155307
• UDI-Public: (01)00801741155307
• 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: 07/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: CTP027015U
• Device Catalogue Number: CTP027015U
• Device Lot Number: CMEN0142
• Date Manufacturer Received: 06/30/2020
• Type of Device Usage: N
• Patient Sequence Number: 1