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U.S. Department of Health and Human Services

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

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COOK INC FLEXOR SHUTTLE TIBIAL GUIDING SHEATH DYB INTRODUCER, CATHETER Back to Search Results
Catalog Number KSAW-7.0-38-80-RB-SHTL
Device Problems Failure to Advance (2524); Split (2537); Deformation Due to Compressive Stress (2889)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/08/2017
Event Type  malfunction  
Manufacturer Narrative
Access was gained from right superficial femoral artery (sfa) to perform the carotid artery stent placement. After the puncture, the flexor shuttle tibial guiding sheath was unable to advance into the artery. The physician suspected that the patient's lesion was calcified; however, calcification was not confirmed by examination. (b)(4). Investigation - evaluation: a review of the complaint history, drawings, device history record, documentation, instructions for use (ifu), manufacturing instructions, specifications, quality control, and visual inspection of the returned device was conducted during the investigation. One used flexor shuttle tibial guiding sheath was returned for evaluation. Biomatter was observed on the end of the sheath. The tip of the sheath appeared to have an indented region, causing a slight bulge. The inner and outer diameter of the sheath tip were measured to be within specification. A document-based investigation was performed. There is no evidence to suggest the finished product was not made to specifications. Review of the device history record of the finished product shows no nonconforming events that could contribute to this failure mode. A complaint history search revealed that there were no other reported complaints for this lot number. Per the ifu, ¿all instruments or catheters used with this product should move freely through the valve and sheath. Do not attempt to insert or withdraw the wire guide and/or introducer if resistance is felt. Upon removal from package, ensure the inner diameter (id) of the introducer is appropriate for the maximum diameter of the instrument or catheter to be introduced. Upon removal from package, inspect the product to ensure no damage has occurred. ¿ based on the information provided, examination of the returned product, and the results of our investigation, the root cause for this event was determined to be related to manufacturing per visual inspection of the device, and as the damage was reported upon initial advancement. Per the quality engineering risk assessment, no further action is required. Appropriate personnel have been notified and monitoring will continue to be performed for similar complaints.
 
Manufacturer Narrative
(b)(4). This event is currently under investigation. A supplemental report will be provided upon conclusion.
 
Event Description
It has been reported that during a carotid artery stent placement procedure, the flexor shuttle tibial guiding sheath had difficulty being advanced. After the physician failed to insert the complaint device, it was confirmed that there was significant tip damage and it could no longer be used. To complete the procedure, a similar device was used. No unintended section of the device remains in the patient, and there have been no adverse effect to the patient reported.
 
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Brand NameFLEXOR SHUTTLE TIBIAL 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 Key7155275
MDR Text Key254046250
Report Number1820334-2017-04582
Device Sequence Number1
Product Code DYB
UDI-Device Identifier00827002311213
UDI-Public(01)00827002311213(17)200725(10)8091262
Combination Product (y/n)N
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 03/14/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/29/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberKSAW-7.0-38-80-RB-SHTL
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 Received02/26/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/25/2017
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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