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

Catalog Number	TA6EBU35
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: evaluation of the returned the device confirmed that the inner and outer diameters of the shaft meet specification.As received the catheter is missing the white soft tip, approximately 2mm in length is torn off at the distal edge of the tip sleeve.The detached tip and the taiga guide catheter were returned and when measured met specification confirming that no part of the device remained in the patient.
Event or Problem Description
The physician intended to use a taiga guide catheter.A radial approach was used.There was no damage noted to packaging.The device was removed from packaging per ifu with no issues.The device was inspected with no issues.The device was prepped per ifu with no issues.Resistance was experienced with the sheath tip when advancing the device due to a spasm in the blood vessel.The catheter was advanced further while being slightly distorted the distortion of the device was due to the resistance.Excessive force was not used.It is indicated that the organic stenosis site developed as a result of the blood vessel spasm and arteriosclerosis.It is reported that during an engagement attempt the distal tip of the device seemed to be torn apart under fluoroscopy.When withdrawing the device, the physician noted that the tip was torn apart and broken off.The fragment was inside the tip of the non-medtronic sheath and was removed by slowly withdrawing the sheath.The procedure was completed under anaesthetic, due to the patient spasm and the procedural approach changed to the inguinal region.The detached portion of the device was removed from the patient before the inguinal region was punctured.The physician stated that if another guide catheter was inserted at the same radial site, the device fragment could not have been retrieved.No patient injury is reported.

• 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: 6940590
• Report Number: 1220452-2017-00101
• Device Sequence Number: 19005778
• Product Code: DQY
• UDI-Device Identifier: 00613994830111
• UDI-Public: 00613994830111
• 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
• Report Date (Section B): 09/12/2017

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: 06/30/2018
• Device Catalogue Number: TA6EBU35
• Device Lot Number: 0008123259
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2017
• Initial Report FDA Received Date: 10/11/2017
• 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
• Patient Age: 70 YR
• Patient Weight: 53