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

Catalog Number	408310RH
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	03/15/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: AGILIS NXT STEERABLE INTRODUCER 22.4MM CURL DIMENSION 8.5FR X 71CM
• Manufacturer (Section D): MEDLINE RENEWAL; 1500 ne hemlock ave; redmond OR 97756
• MDR Report Key: 8520390
• Report Number: 3032391-2019-00008
• Device Sequence Number: 16816686
• Product Code: DYB
• UDI-Device Identifier: 10841898120275
• UDI-Public: 10841898120275
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date (Section B): 04/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

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