MAUDE Adverse Event Report: NATEC MEDICAL LTD. USE® 0.014" PTA RX CATHETER; 0.014" RX PTA CATHETER

Model Number NOT KNOWN

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Type  malfunction  

Manufacturer Narrative

During processing of this complaint, attempts were made to obtain complete event, patient and device information.Since device was not returned for evaluation and no sufficient information were provided, it was not possible to come to a definite conclusion.No non-confirmities concerning pta 0.014" rx catheter has been reported internally concerning the tip detachment till now.Additionally, a review of the complaint history identified no client has till date reported tip detached on use pta 0.014" rx catheter.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Device not returned to manufacturer.

Event Description

Use 0.014" rx pta catheter was used and the tip or a portion of the device broke off in the patient.Migrant piece was snared (retrieved) with not further issue.No patients complication were reported.

• Brand Name: USE® 0.014" PTA RX CATHETER
• Type of Device: 0.014" RX PTA CATHETER
• Manufacturer (Section D): NATEC MEDICAL LTD.; maeva centre building,; ebene business park; reduit, 72201 ; MP 72201
• Manufacturer Contact: xavier buchere ; maeva centre building,; ebene business park; reduit, 72201 ; 4663054
• MDR Report Key: 6088300
• MDR Text Key: 59896579
• Report Number: 3004415014-2016-00001
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152230
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/24/2016,10/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NOT KNOWN
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/23/2016
• Event Location: Hospital
• Date Report to Manufacturer: 03/24/2016
• Date Manufacturer Received: 03/24/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1