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

Catalog Number	TA6JR40
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/26/2017
Type of Reportable Event	Malfunction
Event or Problem Description
The physician was using a taiga guide catheter when treating the rca.There was no damage to the device packaging.The taiga was removed from packaging per ifu with no issues noted.The taiga had been inspected and prepped per ifu with no issues noted.It is reported that when the device was inserted via the transradial approach for pci, the device encountered resistance in the brachial artery.When the device was removed out of the patient¿s body and checked, a tear was noted at the soft tip of the device.Therefore the customer discontinued using the device and completed the procedure with a non-mdt device.No patient injury reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: TAIGA 6F GUIDE CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• MDR Report Key: 6979975
• Report Number: 1220452-2017-00107
• Device Sequence Number: 1117849
• Product Code: DQY
• UDI-Device Identifier: 00613994828743
• UDI-Public: 00613994828743
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K083422
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/02/2019
• Device Catalogue Number: TA6JR40
• Device Lot Number: 0008611521
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/26/2017
• Supplement Date Received by Manufacturer: 02/02/2018
• Initial Report FDA Received Date: 10/26/2017
• Supplement Report FDA Received Date: 03/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 1220452-09-26-2017-001-R
• Patient Sequence Number: 1