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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC TAIGA 6F GUIDE CATHETER; CATHETER, CONDUCTION, ANESTHETIC

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MEDTRONIC, INC TAIGA 6F GUIDE CATHETER; CATHETER, CONDUCTION, ANESTHETIC Back to Search Results
Model Number TA6IL40
Device Problems Peeled/Delaminated (1454); Difficult to Remove (1528); Material Deformation (2976); Material Split, Cut or Torn (4008)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/05/2019
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
A 6f taiga guide catheter was used during a procedure to treat a lesion in the distal right coronary artery (rca).There was no damage noted to the device packaging.The device was removed from the packaging as per ifu.The device was inspected with no issues noted.The device was prepped as per ifu.Resistance was not encountered when advancing the device and excessive force was not used during delivery.It was reported that although the device was delivered to the cusp it failed to be engaged due to the severe tortuosity ranging from the brachiocephalic artery to the ascending aortic.Since the size was not correct the primary curve got stuck at the ostium of the sheath during attempted removal.Force was applied to remove the device, the outer jacket peeled off and the braid was visible.The product was replaced with a ta6sal10 device and the procedure was completed without issues.The patient is alive with no injury.
 
Manufacturer Narrative
Product analysis: received for analysis was one 6f taiga guide catheter coil wrapped with lot# matching that of the complaint file.As received the catheter showed damage to the secondary distal segment.The outer jacket was stretched and torn from the wire braid and inner liner.There was exposed wire braid at the secondary distal segment.The distal portion of the catheter was stretched approximately 4mm.There was bunching of the segment in a distal direction.No other damage noted to the tip, sleeve, primary segment, third segment or shaft.The length of the complaint device was compared to a sample device.The sample device shows what length the guide catheter should be.The length of the complaint device was longer than the device, confirming that it had been stretched.Image analysis: four images were received for analysis.One image shows the entire 6f taiga guide catheter.The remaining images show the outer jacket at the secondary distal segment of the taiga guide catheter has been stretched and broken, exposing the wire braid.There is bunching of the jacket in the distal direction on the catheter.Another image was provided capturing the storage of the devices at the facility.Several 6f taiga guide catheters can be seen along with several other devices within a container, in an upright position and in the outer box.Two other images provided show the outer box and packaging of 6f taiga catheters.If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Additional information: it was stated that although the device was not wiped it may come in contact with saline during preparation of the device.Product is not stored near a light source or any chemicals.If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Additional information: since the size was not correct the primary curve got stuck at the opening of the sheath during attempted removal.Force was applied to remove the device as resistance was noted near the hemostatic valve of the sheath.When removing, the outer jacket peeled off and the braid was visible.After the distributor received the following product, it was further packaged in vinyl for the purpose of keeping the outer package clean, and it was delivered to the hospital within the day.The box was not ruined.During usage, the box / package was unpacked by the staff and the product was removed by the physician.During preparation for use, there were no issues such as kink or peel.It was stated that there were no issues with the storage of the devices in the warehouse until use.If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
TAIGA 6F GUIDE CATHETER
Type of Device
CATHETER, CONDUCTION, ANESTHETIC
Manufacturer (Section D)
MEDTRONIC, INC
37a cherry hill dr
danvers MA 01923
Manufacturer (Section G)
MEDTRONIC, INC
37a cherry hill dr
danvers MA 01923
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
091708734
MDR Report Key8783933
MDR Text Key150837437
Report Number1220452-2019-00086
Device Sequence Number1
Product Code BSO
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K083422
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup,Followup,Followup
Report Date 10/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/18/2021
Device Model NumberTA6IL40
Device Catalogue NumberTA6IL40
Device Lot Number0009602312
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/08/2019
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/05/2019
Initial Date FDA Received07/12/2019
Supplement Dates Manufacturer Received07/22/2019
08/19/2019
09/19/2019
Supplement Dates FDA Received08/21/2019
09/13/2019
10/17/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/19/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age69 YR
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