MAUDE Adverse Event Report: MEDLINE RENEWAL ST. JUDE MEDICAL; AGILIS NXT STEERABLE INTRODUCER 22.4MM CURL DIMENSION 8.5FR X 71CM

Catalog Number 408310RH

Device Problem Break (1069)

Patient Problem Cardiac Tamponade (2226)

Event Date 03/15/2019

Event Type  Injury  

Manufacturer Narrative

It was reported that a reprocessed st.Jude medical's agilis nxt steerable introducer, 22.4mm curl dimension 8.5fr x 71cm, broke during an ablation.Per report, the patient went into cardiac tamponade and the physician drained the accumulated fluids.It was added that the physician is concerned that the "blunt portion is too blunt" and that difficulty was encountered when crossing the septum.Due to the reported event and in an abundance of caution, this medwatch is being filed.The device used for the procedure was returned to innovative health (reprocessor of electrophysiology catheter devices for medline renewal) for evaluation and the complaint could not be confirmed.It was reported that the device functioned as expected.No additional information is available.If additional information becomes available, a supplemental medwatch will be filed.

Event Description

It was reported that the reprocessed agilis nxt steerable introducer broke during an ablation and patient developed cardiac tamponade.

• Brand Name: ST. JUDE MEDICAL
• Type of Device: AGILIS NXT STEERABLE INTRODUCER 22.4MM CURL DIMENSION 8.5FR X 71CM
• Manufacturer (Section D): MEDLINE RENEWAL; 1500 ne hemlock ave; redmond OR 97756
• Manufacturer Contact: stephen wilson ; 1500 ne hemlock ave; redmond, OR 97756
• MDR Report Key: 8520390
• MDR Text Key: 142182382
• Report Number: 3032391-2019-00008
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10841898120275
• UDI-Public: 10841898120275
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date: 04/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 408310RH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2019
• Date Manufacturer Received: 03/18/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention