MAUDE Adverse Event Report: MEDTRONIC IRELAND SPRINTER LEGEND OTW; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Catalog Number SPL12510WL

Device Problem Leak/Splash (1354)

Patient Problems Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Patient Problem/Medical Problem (2688)

Event Date 06/09/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Evaluation summary: the distal tip was damaged.There was no evidence of any material detachment of the balloon.During the analysis the device failed negative prep.Pressure was applied to the device and liquid was seen exiting the balloon, confirming the presence of a leak.A pin-hole leak was detected approx.8.5 mm from the distal tip.The leak site was jagged and uneven.A lead in scratch was evident distal to the leak site.

Event Description

It was reported that the physician was attempting to use a sprinter legend balloon to post-dilate a bifurcation lesion stented in the om and cx, dilating the struts of stent in cx into om.The om had 60-70% stenosis at the ostium and minimal tortuosity.The device was inspected prior to use with no issues noted.Negative prep was performed with no issues.Resistance was noted while advancing to the lesion however excessive force was not used.It is reported that an inflation pressure of 12atm was applied however the balloon never inflated as expected.The physician stated they only saw contrast being injected into the artery.It is reported that the device was pulled back and removed from the body, when the physician noticed the balloon material was no longer on the balloon catheter, it was thought that the balloon material had sheared off the balloon catheter and that the balloon material is still in the left main coronary artery.The procedure was completed.The patient was put on ecmo and is in critical condition.The patient was subsequently taken off ecmo but remained in intensive care.Review of the returned device confirmed that the balloon material has not detached.

Manufacturer Narrative

Medwatch form received from fda, report number mw5063401.The following additional information was contained in the report: the plastic balloon material came off the balloon and embolized to the left main coronary artery leading to hypotension and cardiac arrest.Pt was resuscitated but is critical condition.The patient is now tolerating trach mask but not tracking.Prolonged cardiac arrest and resuscitation contributing to suspect anoxic injury was divelged.Extensive and prolonged care is now expected.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SPRINTER LEGEND OTW
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 5784755
• MDR Text Key: 49231753
• Report Number: 9612164-2016-00666
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/17/2016

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/15/2019
• Device Catalogue Number: SPL12510WL
• Device Lot Number: 0007938879
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/13/2016
• Initial Date FDA Received: 07/12/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/16/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention