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	08/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has been requested and not yet received.The event is currently under investigation.
Event or Problem Description
A flexor ansel guiding sheath was used for a stent placement procedure.It was reported that the end user had the sheath in the patient and placed a zilver ptx stent.The physician then went in with a balloon to post dilate the stent.He pulled the check flo valve off of the sheath in error as he thought he was pulling out the balloon.The wire was in and he placed a new sheath to complete the procedure with no harm to the patient.No unintended section of the device remained inside the patient's body and no adverse effects on the patient were reported due to this occurrence.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, drawings, dimensional verification, device history record, documentation, instructions for use (ifu), manufacturing instructions, specifications, quality control, and visual inspection of the returned device was conducted during the investigation.The sheath of the flexor ansel guiding sheath was returned for evaluation and examined.The sheath tubing was returned separated from the connector cap/ check-flo body.The connector cap was removed from the check-flo body, and no nonconformities were noted.The flare passes through large lumen but does not pass through small lumen.The connector cap was confirmed to be built to specifications.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 could contribute to this failure mode.A complaint history search revealed that 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 root cause of product use or handling related - user technique was determined as the physician pulled the check-flo valve off of the sheath, instead of pulling out the balloon.Per the quality engineering risk assessment, no further action is required.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: 6774193
• Report Number: 1820334-2017-02318
• Device Sequence Number: 10970687
• Product Code: DYB
• UDI-Device Identifier: 00827002299894
• UDI-Public: (01)00827002299894(17)180707(10)6014322
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2017

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-6.0-18/38-90-RB-ANL1-HC
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/04/2017
• Supplement Date Received by Manufacturer: 10/23/2017
• Initial Report FDA Received Date: 08/08/2017
• Supplement Report FDA Received Date: 11/08/2017
• Patient Sequence Number: 1