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

Model Number	TA6AL10
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Patient Problem/Medical Problem (2688); Device Embedded In Tissue or Plaque (3165)
Date of Event	09/04/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician intended to use a taiga 6f guide catheter to treat a mildly tortuous, moderately calcified lesion with chronic total occlusion in cass# 1-2 of the rca.There were no abnormalities reported in relation to anatomy.There was no damage noted to packaging.The device was removed from the packaging per ifu with no issues.The device was inspected with no issues.The device was prepped per ifu with no issues.Resistance was not encountered when advancing the device and excessive force was not used.It is reported that the tip of the device detached during delivery to the lesion.The dislodged fragment was then compressed by a stent in the right coronary artery and remains in the patient.No patient injury was reported.
Additional Manufacturer Narrative
Product analysis summary: the primary curve of the taiga catheter was kinked.The catheter was missing the white soft tip, of which approximately 2mm in length was torn off at the distal edge of the tip sleeve.The tip reportedly remains in the patient.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: 6908085
• Report Number: 1220452-2017-00098
• Device Sequence Number: 1111189
• Product Code: DQY
• UDI-Device Identifier: 00613994830340
• UDI-Public: 00613994830340
• 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): 10/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/09/2018
• Device Model Number: TA6AL10
• Device Catalogue Number: TA6AL10
• Device Lot Number: 0008411526
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2017
• Initial Date Received by Manufacturer: 09/04/2017
• Supplement Date Received by Manufacturer: 09/22/2017
• Initial Report FDA Received Date: 10/02/2017
• Supplement Report FDA Received Date: 10/20/2017
• 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
• Outcome Attributed to Adverse Event: Required Intervention