MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (HEREDIA) INTELLATIP MIFI¿ XP TEMPERATURE ABLATION CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number M004PM4790K20

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/21/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported foreign material was found inside the sterile package.During preparation of the intellatip mifi¿ xp ablation catheter, an object which appeared to be ¿trash¿ was found inside the sterile inner package.The procedure was completed with a different catheter.There were no patient complications.

Event Description

It was reported foreign material was found inside the sterile package.During preparation of the intellatip mifi¿ xp ablation catheter, an object which appeared to be ¿trash¿ was found inside the sterile inner package.The procedure was completed with a different catheter.There were no patient complications.

Manufacturer Narrative

Device evaluated by mfr: the device was returned inside of the original sealed pouch, with the original opened box.Visual inspection confirmed foreign material, measuring greater than 5 square millimeters, moving freely within the sealed pouch.The investigation conclusion is manufacturing execution error as the manufacturing process was not executed as validated/as designed.Updated: device evaluated by mfr., eval summary attached, method codes, result codes, conclusion codes.(b)(4).

• Brand Name: INTELLATIP MIFI¿ XP TEMPERATURE ABLATION CATHETER
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (HEREDIA); 302 parkway; la aurora; heredia ; CS
• MDR Report Key: 7592829
• MDR Text Key: 110801638
• Report Number: 2134265-2018-05147
• Device Sequence Number: 1
• Product Code: OAD
• UDI-Device Identifier: 08714729848059
• UDI-Public: 08714729848059
• Combination Product (y/n): N
• PMA/PMN Number: P020025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 05/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2020
• Device Model Number: M004PM4790K20
• Device Catalogue Number: PM4790K2
• Device Lot Number: 0021456436
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2018
• Initial Date Manufacturer Received: 05/21/2018
• Initial Date FDA Received: 06/12/2018
• Supplement Dates Manufacturer Received: 07/03/2018
• Supplement Dates FDA Received: 07/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1