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

Catalog Number	KSAW-6.0-18/38-55-RB-ANL1-HC
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/31/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.
Event or Problem Description
It was reported the device was used to treat a superficial femoral artery (sfa) by contralateral approach.Another manufacturer's wire guide "radifocus" was inserted into the puncture site.When the user attempted to advance the flexor ansel guiding sheath over the wire guide, the wire guide would not be inserted into the dilator tip.Therefore, the user changed the orientation of the flexor at 180 degrees and advanced it from the proximal end (hub side) over the wire guide.Then, the wire guide could pass through the entire length of the dilator, so the user changed the orientation of the flexor back again and advanced the dilator from the tip over the wire guide successfully.The procedure was completed with the flexor sheath.There have been no adverse effects to the patient reported.The physician reported that the dilator tip was checked carefully prior to use, but no issue was visually found.Also, no foreign matter exited from the dilator which could have blocked the inner lumen.Per further review, it was noted that the hydrophilic coating was scratch/ flaked.

• 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: 6572776
• Report Number: 1820334-2017-01186
• Device Sequence Number: 628222
• Product Code: DYB
• UDI-Device Identifier: 00827002299962
• UDI-Public: (01)00827002299962(17)190113(10)6516753
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/17/2017

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 Catalogue Number: KSAW-6.0-18/38-55-RB-ANL1-HC
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2017
• Initial Report FDA Received Date: 05/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TERUMO RADIFOCUS GUIDEWIRE