MAUDE Adverse Event Report: TFX ENGINEERING LIMITED T/A IMAGER II ANGIOGRAPHIC CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number M001314141

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr.: returned product consisted of an imager diagnostic catheter in the pouch only.No shipping carton was returned.The pouches were returned opened on one end.The pouches and the remainder of the device were inspected for damage and revealed no other damage or irregularities.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The root cause has been determined to be related to a supplier manufacturing issue.(b)(4).

Event Description

Same case as: 2134265-2016-12039 and 2134265-2016-12040.Reportable based on device analysis completed on (b)(6) 2016.It was reported that the box was not sealed.An imager ii angiographic catheters were delivered to the facility, however, it was noticed that the bottom package was not sealed and the catheters were slipping out.There were no patient involvement.However, device analysis revealed that the inner pouch was opened on one end.

• Brand Name: IMAGER II ANGIOGRAPHIC CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): TFX ENGINEERING LIMITED T/A; estate; limerick
• Manufacturer (Section G): TFX ENGINEERING LIMITED T/A; estate; limerick
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6168605
• MDR Text Key: 62198985
• Report Number: 2134265-2016-12037
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120893
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/11/2018
• Device Model Number: M001314141
• Device Catalogue Number: 31-414
• Device Lot Number: 0000112758
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1