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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC ADVANCE 14 LP LOW PROFILE BALLOON CATHETER DQY CATHETER, PERCUTANEOUS

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COOK INC ADVANCE 14 LP LOW PROFILE BALLOON CATHETER DQY CATHETER, PERCUTANEOUS Back to Search Results
Catalog Number PTAX4-14-170-2-20
Device Problem Material Perforation (2205)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/11/2018
Event Type  Malfunction  
Manufacturer Narrative

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 angioplasty of a calcified lesion below-the-knee, an advance 14 lp low profile balloon catheter perforated longitudinally. The vessel was not angulated. According to the complainant, the inflation was approximately 8 to 16 atmospheres (atm) but not greater than burst pressure. A 6fr ansel sheath and wire guide were used in conjunction with the complaint device. The complaint advance 14 lp low profile balloon catheter was removed from the patient's anatomy and another was used to successfully complete the procedure. No patient adverse effect was reported. The patient did not retain any balloon fragment.

 
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Brand NameADVANCE 14 LP LOW PROFILE 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 Key7938402
MDR Text Key123209004
Report Number1820334-2018-03062
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeKR
PMA/PMN NumberK090822
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 01/22/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/05/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberPTAX4-14-170-2-20
Device LOT Number8792434
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/22/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/21/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/23/2018
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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