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U.S. Department of Health and Human Services

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

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COOK INC FLEXOR ANSEL GUIDING SHEATH DYB INTRODUCER, CATHETER Back to Search Results
Catalog Number KCFW-7.0-18/38-45-RB-ANL2-HC
Device Problems Kinked (1339); Split (2537)
Patient Problem No Patient Involvement (2645)
Event Date 12/14/2017
Event Type  malfunction  
Manufacturer Narrative
Investigation ¿ evaluation: a review of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, quality control, and a visual inspection of the returned device were conducted during the investigation. The visual inspection of the returned device confirmed that the (b)(4)" dilator had two cuts present on the distal tip. One cut was measured to be (b)(4) in length, and the other was measured to be (b)(4 in length. Additionally, a document based investigation evaluation was performed. There is no evidence to suggest the product was not made to specifications. A review of the device history record showed 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, the examination of the returned product, and the results of our investigation, a definitive root cause could not be determined. It is possible, however, that package handling related to shipment and storage conditions, could have contributed to the event. We will continue to monitor for similar complaints. Per the quality engineering risk assessment, no further action is required.
 
Manufacturer Narrative
(b)(4). The event is currently under investigation. A supplemental report will be provided upon conclusion.
 
Event Description
It was reported that prior to a procedure, the flexor ansel guiding sheath tip was observed to be split/ kinked. The sheath did not come into contact with a patient. According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
 
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Brand NameFLEXOR ANSEL GUIDING SHEATH
Type of DeviceDYB INTRODUCER, CATHETER
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
larry pool
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key7151423
MDR Text Key113932205
Report Number1820334-2017-04571
Device Sequence Number1
Product Code DYB
UDI-Device Identifier00827002299863
UDI-Public(01)00827002299863(17)200522(10)7930427
Combination Product (y/n)N
Reporter Country CodeKR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/03/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/28/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberKCFW-7.0-18/38-45-RB-ANL2-HC
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/08/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/22/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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