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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 PTAX4-14-170-2.5-12
Device Problems Split (2537); Physical Resistance (2578)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/15/2016
Event Type  Malfunction  
Manufacturer Narrative

This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable. Additional complaint investigation and record remediation was not performed.

 
Event Description

The complainant reported that the advance 14 lp low profile balloon catheter was advanced over the wire guide after the wire guide passed through the target lesion. However, the physician experienced resistance during advancement. Resistance was also felt when removing the complaint device from the patient. Another device was used to complete the procedure. It was further noted that there was a split in the balloon on the complaint device. There were no reported serious injuries to the patient as a result of the product problem.

 
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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 Contact
larry pool
750 daniels way
bloomington, IN 47404
8128294891
MDR Report Key7602421
MDR Text Key111681147
Report Number1820334-2018-01811
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,OTHER,USER FACILITY
Reporter Occupation
Type of Report Initial
Report Date 06/14/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/14/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberPTAX4-14-170-2.5-12
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 Received06/06/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/15/2015
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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