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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH; DYB INTRODUCER, CATHETER
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COOK INC FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH; DYB INTRODUCER, CATHETER Back to Search Results
Catalog Number KCFW-6.0-35-70-RB-HFANL1-HC
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Reaction (2414)
Event Date 07/24/2018
Event Type  Injury  
Manufacturer Narrative
Blank fields on this form indicate the information is unknown, or unavailable.Pma/510(k) number = pre-amendment.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.
 
Event Description
It was reported, during an angioplasty of the pulmonary arteries, a patient experienced a suspected allergic reaction to a cook flexor high-flex ansel guiding sheath (lot number is uncertain).Upon insertion of the complaint device via the right femoral vein, the patient experienced ocular revulsion, tachycardia, flush, and a suspected convulsion.Hemodynamics were preserved.The symptoms resolved within one minute without intervention and the procedure was completed as originally planned.The procedure occurred outside the united states.The patient reported a previous pulmonary angioplasty performed in (b)(6) 2018 without issue.Additionally, the patient reported no allergies; however, there was an allergy to eggs, strawberries, and meats in her youth.These allergies reportedly resolved without intervention.The patient's significant past medical history includes post embolic pulmonary artery hypertension treated with adempas, recurrent pulmonary embolism on deep thrombophlebitis treated with long term avk, ischemic heart disease with angioplasty in 1999, hypertension, diabetes type ii, dyslipidemia, irc on single kidney with dfg of 3.0 ml/min, thyroidectomy.According to the initial reporter, no additional adverse effects have been reported.No additional procedures were required.Additional information regarding event details has been requested, but is not available at this time.It was reported, the device will not be returned to the manufacturer for investigation.
 
Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: additional information was received from the customer.As part of the initial procedure, xylocaine medication was administered.No treatment or medication was administered as a result of the physiological and potentially allergic response of the patient.The sheath was used to complete the procedure and was not removed, and the patient's overall outcome was reportedly very good following the reported intervention.Investigation evaluation: a review of the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, and quality control of the device was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document based investigation evaluation was performed.While the lot number of the device was not known, it was confirmed that the device belonged to one of three lots.A review of each of the device history records for these lots was conducted.The first lot (lot 8582403) shows no nonconforming events which could contribute to this failure mode; however, there was one other reported complaint for this lot number.The second lot (lot 8667640) shows two nonconforming events which could contribute to this failure mode; however, there were no other reported complaints for this lot number.The third lot (lot 8836004) shows one nonconforming event which could contribute to this failure mode; however, there were no other reported complaints for this lot number.Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined.Measures are being conducted to address this failure mode.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
 
Event Description
Additional information regarding the patient and or event has been received since the previous medwatch report was sent.This information is detailed in h10.
 
Manufacturer Narrative
Upon further review of the complaint it was determined that the event is not reportable under fda 21 cfr part 803 as it does not meet the criteria for a death, serious injury or reportable product malfunction.There is no reported product malfunction.Furthermore, the reported symptoms experienced by the patient did not require any medical or surgical intervention.Blank fields on this form indicate the information is unknown, unchanged, or unavailable.H1: this event does not meet the criteria for a malfunction, serious injury, or death.This report includes information known at this time.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
 
Event Description
Upon further review of the complaint it was determined that the event is not reportable under fda 21 cfr part 803 as it does not meet the criteria for a death, serious injury or reportable product malfunction.There is no reported product malfunction.Furthermore, the reported symptoms experienced by the patient did not require any medical or surgical intervention.
 
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Brand Name
FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH
Type of Device
DYB INTRODUCER, CATHETER
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
MDR Report Key7767729
MDR Text Key116593095
Report Number1820334-2018-02321
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 10/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/09/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date02/13/2021
Device Catalogue NumberKCFW-6.0-35-70-RB-HFANL1-HC
Was Device Available for Evaluation? No
Date Manufacturer Received10/02/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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