MAUDE Adverse Event Report: COVIDIEN GOOSENECK SNARE; CATHETER, PERCUTANEOUS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pulmonary Embolism (1498); Hemorrhage/Bleeding (1888)

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic conducted a post market clinical follow-up (pmcf) survey to seek out potential new risks and assess performance of the amplatz goose neck snare kit and the amplatz goose neck microsnare kit.Survey results from an interventional cardiologist in practice 13 years.Physician has been using medtronic¿s amplatz goose neck snare kit and amplatz microsnare kit since 2015, using a total of 9 amplatz goose neck snare kits and 5 amplatz goose neck microsnare kits in the last year.Of the amplatz goose neck microsnare kits used, 3 were used during peripheral vascular procedures, 1 used during a coronary vascular procedure, and 1 used during an extra-cranial neurovascular procedure.During use of the amplatz goose neck snare kit a stroke event was reported in 1 patient during use in the arterial vasculature reported as an ischemic stroke reversible after three months but fortunately without sequela.During use of the amplatz goose neck snare kit in the venous vasculature, a pulmonary embolism event was reported for 1 patient which required oxygen and anticoagulants for one month.During use of the amplatz goose neck snare kit, device entrapment during a slow and dangerous procedure (1 patient) and vessel damage described as a non-severe haemorrhage which spontaneously resolved without open surgery (1 patient) are other reported complications during use of the device.During use of the amplatz goose neck snare kit, there is one event reported with stripping fibrin sheath from an indwelling catheter resulting in catheter damage on small-bore catheter which required definitive replacement.During use of the amplatz goose neck microsnare kit no complications were reported during use in the arterial vasculature or venous vasculature.During use of the amplatz goose neck microsnare kit in coronary vasculature a myocardial infarction (depending on placement) was reported for 1 patient.This was reported as being a severe heart attack that required intensive care for 7 days.During use of the amplatz goose neck microsnare kit in extra-cranial neurovasculature, a stroke event is reported for 1 patient which was described as mild and resolved without reliquaries in about a month no other complications are reported during use of the amplatz goose neck microsnare kit.Of the above complications (adverse events), some of these are listed as having been reported to medtronic previously.Due to limited information these are included in reporting.

• Brand Name: GOOSENECK SNARE
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 8620329
• MDR Text Key: 145390750
• Report Number: 2183870-2019-00272
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K970668
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/08/2019
• 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; Required Intervention