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

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Respiratory Distress (2045)
Date of Event	11/14/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported a vascular surgeon was performing a procedure on the subclavian.The sheath was being introduced when the patient began to have a anaphylactic episode, which included respiratory distress and the patient became a deep red color.The physician aborted the procedure at this time.¿the patient was stabilized and fine and able to leave the hospital.¿ reportedly ¿the same type of episode occurred with the patient a couple months ago.¿ the manufacturer has requested additional information about this event, as of the date of this report a response has not been received.The patient was sent to work with an allergist in (b)(6), the allergist is working with the manufacturers product manager to determine the make and materials used to manufacturer this product as it may have contributed to the patient's allergic reaction.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
Additional information: previous occurrence with this patient is reported in 1820334-2016-01628.Investigation - evaluation: a review of the complaint history, drawings, device history record, documentation, instructions for use (ifu), specifications, trends, and quality control of the device was conducted during the investigation.The device is shipped with an instruction for use (ifu) that describes the intended use; specific items are addressed such as: "supplied sterilized by ethylene oxide gas in peel-open packages.Intended for one-time use.Sterile if package is unopened or undamaged.Do not use the product if there is doubt as to whether the product is sterile.Store in a dark, dry, cool place.Avoid extended exposure to light." the flexor ansel guiding sheath was not returned therefore, no physical examinations could be performed.A document based investigation evaluation was 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.It should be noted there were no other reported complaints for this lot number.Based on all of the available information, no product returned and the results of our investigation, a definitive root cause to the reported event could not be conclusively determined.Contributing factors may be related to the patient's previous history of allergic reaction which had not been reported by the treating physician until the occurrence of this event.We will continue to monitor for similar complaints.Per the risk assessment no further action is required.

• 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: 6186161
• Report Number: 1820334-2016-01510
• Device Sequence Number: 13716514
• Product Code: DYB
• UDI-Device Identifier: 00827002299962
• UDI-Public: (01)00827002299962(17)190519(10)6982433
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: KSAW-6.0-18/38-55-RB-ANL1-HC
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/23/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/19/2016
• Supplement Report FDA Received Date: 06/22/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 16 YR