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

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Intraoperative Pain (2662)
Date of Event	04/28/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).This event is currently under investigation.
Event or Problem Description
It was reported that contralateral access was gained for a lower leg angiogram.At the end of the procedure, the user attempted to remove the sheath to close the right common femoral vessel.The dilator was placed back in the sheath and the sheath fractured; a fragment remained in the patient.The fragment was retrieved using a balloon.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 experienced additional pain due to this occurrence.
Additional Manufacturer Narrative
Investigation - evaluation : a review of the complaint history, drawings, device history record, documentation, instructions for use (ifu), specifications, quality control and visual inspection of the returned device was conducted during the investigation.One flexor introducer sheath was returned for investigation.No damage was noted to the dilator/hub.The coil wire which was exposed past the external coating is 1.7 cm.A document based investigation evaluation was also performed.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.There were no other reported complaints for this lot number.Based on the information provided and results of the investigation a definitive root cause could not be determined.Per the quality engineering risk assessment no further action is required.Monitoring for similar complaints will continue.

• 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: 6593812
• Report Number: 1820334-2017-00994
• Device Sequence Number: 802156
• Product Code: DYB
• UDI-Device Identifier: 00827002132122
• UDI-Public: (01)00827002132122(17)200313(10)7744822
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2017

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: KCFW-5.0-38-RB
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/28/2017
• Supplement Date Received by Manufacturer: 07/07/2017
• Initial Report FDA Received Date: 05/26/2017
• Supplement Report FDA Received Date: 07/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention