MAUDE Adverse Event Report: COOK INC FLEXOR INTRODUCER 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	11/10/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported during a fenestrated thoraco procedure as the introducer sheath was being brought onto another manufacturer's wire the sheath detached from the tap section.The wire was reported to be coming from the brachial (above) crossing the great vessels to the descending aorta at the time.Another device was used to successfully complete the procedure.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
A review of the complaint history, drawings, dimensional verification, device history record, manufacturing instructions, trends, quality control and visual inspection of the returned device was conducted during the investigation.The visual inspection of the returned device reported and device failure analysis reported one used kcfw-7.0-38-90-rb device was returned for investigation with the check-flo assembly separated from the sheath.The sheath flare was found to be slightly distorted.No other visible signs of damage to the sheath tubing were observed.A go, no-go flare gauge was used to verify the flare size was manufactured to specification.Using pin gauges, the inner diameter of the connector cap was measured to be 0.138 in.Per drawings, the id of the connector cap is specified as 0.136 +/- 0.002 in.It was reported that no major force was being exerted at the time of separation.Manufacturing instructions and quality control instruction were reviewed and did not identify any issues that would attribute to the reported failure.There is no evidence to suggest the product was not made to specifications.Review of device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the information provided and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the health risk assessment no further action is required.

• Brand Name: FLEXOR INTRODUCER SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6145481
• Report Number: 1820334-2016-01436
• Device Sequence Number: 16339585
• Product Code: DYB
• UDI-Device Identifier: 00827002116177
• UDI-Public: (01)00827002116177(17)190524(10)6993223
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2016

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-7.0-38-90-RB
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/10/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/05/2016
• Supplement Report FDA Received Date: 01/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1