MAUDE Adverse Event Report: COOK INC FLEXOR HIGH-FLEX 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	02/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The reported device has been received, an evaluation is in progress.
Event or Problem Description
It was reported during an abdominal aortic aneurysm repair procedure, the vascular surgeon introduced the flexor high-flex ansel guiding sheath(sheath and dilator).When the surgeon went to retrieve the dilator, the proximal part of the dilator disconnected.The vascular surgeon exchanged this flexor high-flex ansel guiding sheath out for another one with a different lot number.There were no problems with the new one.The patient was unharmed.No additional details have been received.
Additional Manufacturer Narrative
A section of the device did not remain inside the patient's body.It was reported that more time had to be spent in the procedure as the user had to completely change the introducer.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Evaluation- one used flexor high-flex ansel guiding sheath was returned to assist with the evaluation.It was noted that the hub was separated from the dilator and biomatter was present.The dilator flare appeared to have been manufactured too small.This was likely caused by insufficient cooling during the flaring manufacturing process.The device history record was reviewed and noted four devices were detected to have been manufactured out of specifications.Measures have been previously initiated to address this non-conformance.A quality engineer risk assessment was conducted to evaluate the risk of this event.Based on the results of the analysis, further risk reduction is not required due to a low occurrence.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.

• Brand Name: FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6396474
• Report Number: 1820334-2017-00363
• Device Sequence Number: 13460276
• Product Code: DYB
• UDI-Device Identifier: 00827002477018
• UDI-Public: (01)00827002477018(17)190411(10)6880122
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2017

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-12.0-35-45-RB-HFANL1-HC
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/09/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/10/2017
• Supplement Report FDA Received Date: 04/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1