MAUDE Adverse Event Report: COOK INC FLEXOR ANSEL GUIDING SHEATH; DYB INTRODUCER, CATHETER

Catalog Number	KSAW-6.0-18/38-55-RB-ANL1-HC
Medical Device Problem Codes	Material Frayed (1262); Failure to Advance (2524)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A supplemental report will be provided upon conclusion.
Event or Problem Description
It was reported that during treatment of a chronic total occlusion (cto) lesion of the superficial femoral artery (sfa), the dilator was inserted and the flexor ansel guiding sheath was attempted to be advanced using a contralateral approach from the femoral artery to the cto.A calcified lesion was noted to be present at the femoral artery (access site), and the sheath was unable to enter the artery as the tip had a blunt edge.As a result, the sheath tip became frayed, and another manufacturer's device was utilized to complete the procedure.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a review of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, and quality control of the device was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there was one other reported complaint for this lot number.Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined.It is likely, however, that patient condition contributed to the event.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• Brand Name: FLEXOR ANSEL GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7151481
• Report Number: 1820334-2017-04624
• Device Sequence Number: 933298
• Product Code: DYB
• UDI-Device Identifier: 00827002299962
• UDI-Public: (01)00827002299962(17)200425(10)7857227
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2018

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 Catalogue Number: KSAW-6.0-18/38-55-RB-ANL1-HC
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/18/2017
• Supplement Date Received by Manufacturer: 03/01/2018
• Initial Report FDA Received Date: 12/28/2017
• Supplement Report FDA Received Date: 03/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1