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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC ADVANCE MICRO ¿ 14 ULTRA LOW-PROFILE PTA BALLOON CATHETER DQY CATHETER, PERCUTANEOUS

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COOK INC ADVANCE MICRO ¿ 14 ULTRA LOW-PROFILE PTA BALLOON CATHETER DQY CATHETER, PERCUTANEOUS Back to Search Results
Model Number G26677
Device Problem Material Perforation (2205)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/14/2018
Event Type  Malfunction  
Manufacturer Narrative

(b)(6). Pma/510(k) number: pre-amendment. This report includes information known at this time. A follow-up report will be submitted at the conclusion of the investigation or, when additional relevant information becomes available.

 
Event Description

It was reported, a (b)(6) year old female patient underwent an angioplasty of the right lower limb using an advance micro 14 ultra low-profile pta balloon catheter. The balloon was passed until it reached the injury. It was then observed through fluoroscopy that it did not inflate. The complaint balloon was removed and a perforation was seen at the distal end of the balloon. Another balloon was used to complete the procedure. A section of the device did not remain inside the patient¿s body. 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.

 
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Brand NameADVANCE MICRO ¿ 14 ULTRA LOW-PROFILE PTA BALLOON CATHETER
Type of DeviceDQY CATHETER, PERCUTANEOUS
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer (Section G)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
larry pool
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key8677228
MDR Text Key147622837
Report Number1820334-2019-01294
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK122940
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR,FOREIGN,HEALTH PR
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/19/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/06/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date10/06/2020
Device MODEL NumberG26677
Device Catalogue NumberPTA3-14-150-2.5-8
Device LOT Number8273187
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/11/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/06/2017
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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