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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC MICROPUNCTURE TRANSITIONLESS ACCESS SET DYB INTRODUCER, CATHETER

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COOK INC MICROPUNCTURE TRANSITIONLESS ACCESS SET DYB INTRODUCER, CATHETER Back to Search Results
Catalog Number MPIS-401-NT-U-SST
Device Problems Split (2537); Wrinkled (2614)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/09/2018
Event Type  malfunction  
Manufacturer Narrative
Investigation ¿ evaluation: a review of the complaint history, device history record, documentation, drawing, quality control, specifications, and a visual inspection of the returned device were conducted during the investigation. The visual inspection of the returned device confirmed the presence of 2 mm of wrinkle damage on the distal tip of outer catheter. There was a smooth transition between the inner and outer catheters, but this was disrupted by the damage present on the distal tip of the outer catheter. Additionally, a document based investigation evaluation was performed. A review of the device history record showed three nonconforming events which could contribute to this failure mode; however, all devices involved were reworked. 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 plausible, however, that patient condition 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). 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 that during treatment of a chronic total occlusion (cto) lesion in the patient's superficial femoral artery (sfa), access was gained from the popliteal artery. The physician punctured the site and placed the micropuncture transitionless access set sheath, at which point the sheath tip was damaged by the calcified lesion. Another micropuncture set was utilized to successfully complete the procedure. According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
 
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Brand NameMICROPUNCTURE TRANSITIONLESS ACCESS SET
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 Key7200135
MDR Text Key273376452
Report Number1820334-2018-00179
Device Sequence Number1
Product Code DYB
UDI-Device Identifier00827002479449
UDI-Public(01)00827002479449(17)201012(10)8290309
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/06/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/17/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberMPIS-401-NT-U-SST
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 Received03/13/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/12/2017
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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