MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ULTRA ICE PLUS; CATHETER, ULTRASOUND, INTRACARDIAC

Model Number 86200

Device Problem Material Perforation (2205)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/01/2020

Event Type  malfunction  

Manufacturer Narrative

It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.

Event Description

It was reported that a ultra ice plus was selected for used in a atrial fibrillation ablation procedure.After the catheter was inserted into the patient it was noted to be not working properly.The catheter was removed from the patient and was noted to have a crack in the catheter lining.The procedure was completed using another ultra ice plus catheter without patient complications.

Manufacturer Narrative

The returned device was reported for crack in catheter lining.Visual inspection revealed that the sheath assembly had a partial detachment.The flush port in the distal section of the device was damaged.No other damages were observed.It was not possible to flush the catheter due to the detachment observed in the sheath assembly.Microscope inspection revealed that the sheath assembly had a partial detachment as well as a damage in the flush port in the distal end.Based on the information provided, there is no evidence that the device was used in a manner inconsistent with the labeled indications.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.

Event Description

It was reported that a ultra ice plus was selected for used in a atrial fibrillation ablation procedure.After the catheter was inserted into the patient it was noted to be not working properly.The catheter was removed from the patient and was noted to have a crack in the catheter lining.The procedure was completed using another ultra ice plus catheter without patient complications.

• Brand Name: ULTRA ICE PLUS
• Type of Device: CATHETER, ULTRASOUND, INTRACARDIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10479574
• MDR Text Key: 205263790
• Report Number: 2134265-2020-12161
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 08714729904380
• UDI-Public: 08714729904380
• Combination Product (y/n): N
• PMA/PMN Number: K160173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/05/2021
• Device Model Number: 86200
• Device Catalogue Number: 86200
• Device Lot Number: 0024887480
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2020
• Date Manufacturer Received: 10/23/2020
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 100