MAUDE Adverse Event Report: COVIDIEN MICROSNARE; CATHETER, PERCUTANEOUS

Device Problem No Apparent Adverse Event (3189)

Patient Problems Pulmonary Embolism (1498); Embolism (1829); Myocardial Infarction (1969); 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 an interventional cardiologist in practice 14 years: physician has been using medtronic¿s amplatz goose neck snare kit and amplatz microsnare kit since 2017, using a total of 100 amplatz goose neck snare kits and 50 amplatz goose neck microsnare kits in the last year.Of the amplatz goose neck microsnare kits used, 10 were used during peripheral vascular procedures, and 40 were used during coronary vascular procedures.During use of the amplatz goose neck snare kit in the arterial vasculature embolization during peripheral cases is reported to have occurred in 5 patients, and myocardial infarction in anterior wall (5 patients).During use of the amplatz goose neck snare kit in the venous vasculature, a pulmonary embolism event was reported for 1 patient.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.Other complications encountered during use of the amplatz goose neck snare kit are reported as infection in 1 patient.During use of the amplatz goose neck microsnare kit in the arterial vasculature, embolization during peripheral cases is reported to have occurred in 1 patient, and myocardial infarction in 1 patient.During use of the amplatz goose neck microsnare kit in the venous vasculature, a pulmonary embolism event was reported for 1 patient.During use of the amplatz goose neck microsnare kit in coronary vasculature an embolization event and a stroke event are reported for 1 patient each other complications encountered during use of the amplatz goose neck microsnare kit are reported as vessel damage reported as "boral" renal function in 1 patient 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: MICROSNARE
• 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: 8626884
• MDR Text Key: 145614060
• Report Number: 2183870-2019-00279
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K925439
• 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