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

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported during an unspecified procedure using a flexor ansel guiding sheath, that the sheath got separated from the hub during use, so it was replaced with another manufacturer's device.There have been no adverse effects to the patient reported.
Additional Manufacturer Narrative
Correction: report source foreign, health professional, user facility.Additional information: information received indicating the procedure was performed via the trans-radial approach.Investigation - evaluation: a review of the complaint history, drawings, device history record, documentation, manufacturing instructions, quality control and visual inspection of the returned device was conducted during the investigation.The flexor ansel guiding sheath and the 0.35" endhole dilator of the flexor ansel guiding sheath were returned for evaluation.The sheath was returned with the proximal fittings separated from the tubing.The flare was round and the diameter of the flare was 3.4mm.The outside diameter of the sheath tubing was 0.07426 inches.Compression marks were noted on the sheath tubing at 4.0cm, 4.5cm, and 6.0cm, measuring from the proximal end of the tubing.Two wrinkles, each 1 mm in length, were noted on the distal tip of the tubing.The check-flo body was separated from the connector cap.Compression marks were noted around the check-flo cap.The flare passed through the large lumen as well as the small lumen.The flare could have been compressed or met with forces while separation.The connector cap accepts a maximum of 0.084" pin gauge.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 were no other reported complaints for this lot number.Based on the information provided, examination of the returned product, and the results of our investigation; a definitive root cause could not be determined.Measures have been conducted to address this failure mode.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: 6646478
• Report Number: 1820334-2017-01242
• Device Sequence Number: 19095140
• Product Code: DYB
• UDI-Device Identifier: 00827002481862
• UDI-Public: (01)00827002481862(17)171104(10)5414713
• Combination Product (Y/N): N
• 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): 09/25/2017

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: KCFW-4.0-18/35-45-RB-ANL0-HC
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/18/2017
• Supplement Date Received by Manufacturer: 09/12/2017
• Initial Report FDA Received Date: 06/16/2017
• Supplement Report FDA Received Date: 09/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1