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

Device Problems Device Damaged by Another Device (2915); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

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 15 years.Physician has been using medtronic¿s amplatz goose neck snare kit and amplatz microsnare kit since 2010, using a total of6 amplatz goose neck snare kits and 9 amplatz goose neck microsnare kits in the last year.Of the amplatz goose neck microsnare kits used, 4 were used during peripheral vascular procedures, 5 were used during coronary vascular procedures.During use of the amplatz goose neck snare kit in the arterial vasculature the following complications were reported: embolization (3 patients) due to a stent being loose and embolising, myocardial infarction (1 patient) during removal of loose stent from embolised coronary, and stroke (2 patients) due to embolization of a 4fr catheter fragment.During use of the amplatz goose neck snare kit in the venous vasculature, a pulmonary embolism event was reported for 1 patient which occurred when removing the end of a porthacath tubing.One device entrapment event during removal of a pacemaker probe was also reported as a complication during use of the amplatz goose neck snare kit.During use of the amplatz goose neck snare kit, there is one event reported with stripping fibrin sheath from an indwelling catheter (1 patient), and pulmonary embolism (1 patient) where it is reported porthacath tubing embolised during use of the amplatz goose neck microsnare kit in arterial vasculature: an embolization (1 patient) event due to pulmonary artery wound without consequence, myocardial infarction (1 patient) due to embolization of a guide fragment, and stroke (1 patient) due to detachment of atherosclerosis plaque are reported complications during use of the amplatz goose neck microsnare kit in venous vasculature: pulmonary embolism (1 patient) is reported as a complication.During use of the amplatz goose neck microsnare kit in coronary vasculature a stroke (1 patient) was reported.Infection (1 patient) is also reported as a complication associated with use of 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: 8620279
• MDR Text Key: 145395251
• Report Number: 2183870-2019-00271
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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?: No
• Is this a Product Problem Report?: Yes
• 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