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

Model Number	N/A
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This event is under investigation.
Event or Problem Description
It was reported during treatment of a superficial femoral artery (sfa) using a flexor ansel guiding sheath, contralateral approach was gained from the groin to treat the sfa.After insertion of a 4fr.Short sheath, the physician attempted to insert the device into the patient.It was reported that it could not be inserted into the vessel resulting in damage (fray) in the device tip.Then, it was replaced with a competitor's device and the procedure was completed successfully.There have been no adverse effects to the patient reported.
Additional Manufacturer Narrative
Corrected information: foreign, health professional, user facility.Investigation - evaluation: a review of the complaint history, drawings, device history record, documentation, instructions for use (ifu), manufacturing instructions, quality control, and inspection of unused product was conducted during the investigation.The complaint device was not returned to aid the investigation.No images/videos of the failure were provided.A representative flexor ansel guiding sheath was obtained from the complaint lot for testing purposes.There appeared to be no non-conformities on the 0.018" and 0.038" endhole dilator tips.The sheath had an open lumen and accepted both the dilators.It also accepted a 0.086" checker with no difficulty.The o.D of the 0.038" and 0.0018" dilators measured 0.0855" and 0.0853" respectively.The dilators accepted the respective wire guides.The wire advanced through the tubing with no difficulty.The dilator tip was tapered to a smooth transition.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows no nonconforming events that would contribute to this failure mode.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.Per the health risk assessment, no further action is required.Appropriate personnel have been notified and monitoring will continue to be performed for similar complaints.

• 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: 6662629
• Report Number: 1820334-2017-01395
• Device Sequence Number: 132544
• Product Code: DYB
• UDI-Device Identifier: 00827002299962
• UDI-Public: (01)00827002299962(17)190426(10)6917658
• 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): 09/14/2017

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 Model Number: N/A
• Device Catalogue Number: KSAW-6.0-18/38-55-RB-ANL1-HC
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/24/2017
• Supplement Date Received by Manufacturer: 09/12/2017
• Initial Report FDA Received Date: 06/23/2017
• Supplement Report FDA Received Date: 09/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1