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

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

Patient Problems Unspecified Infection (1930); Perforation (2001); Patient Problem/Medical Problem (2688)

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 a cardiac, vascular & thoracic surgeon in practice 13 years: physician has been using medtronic¿s amplatz goose neck snare kit and amplatz microsnare kit since 2017, using a total of 15 amplatz goose neck snare kits and 24 amplatz goose neck microsnare kits in the last year.Of the amplatz goose neck microsnare kits used, 5 were used during peripheral vascular procedures, 20 were used during coronary vascular procedures and 5 were used during extra-cranial neurovascular procedures during use of the amplatz goose neck snare kit in the arterial vasculature and venous vasculature, no complications were reported.C omplications reported during use of the device were reported as post op infection on second day (3 patients), lengthened procedure due to staffing (2 patients), vessel damage during manipulation (3 patients), and vessel perforation during manipulation (4 patients).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 reported as an interoperative complication.During use of the amplatz goose neck microsnare kit in the arterial vasculature, venous vasculature, coronary vasculature and extra-cranial neurovasculature no complications were reported.Complications reported during use of the device were reported as device entrapment between two devices (2 patients), post op infection on second day (1 patients), vessel damage during manipulation (2 patients), and vessel perforation during manipulation (1 patients) 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: 8627339
• MDR Text Key: 145627393
• Report Number: 2183870-2019-00285
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 05/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2019
• 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