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

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.

• 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 Key: 8783933
• MDR Text Key: 150837437
• Report Number: 1220452-2019-00086
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K083422
• 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,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 Date: 02/18/2021
• Device Model Number: TA6IL40
• Device Catalogue Number: TA6IL40
• Device Lot Number: 0009602312
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/05/2019
• Initial Date FDA Received: 07/12/2019
• Supplement Dates Manufacturer Received: 07/22/2019; 08/19/2019; 09/19/2019
• Supplement Dates FDA Received: 08/21/2019; 09/13/2019; 10/17/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 69 YR