• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC ADVANCE 14 LP LOW PROFILE BALLOON CATHETER LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

COOK INC ADVANCE 14 LP LOW PROFILE BALLOON CATHETER LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number N/A
Device Problem Torn Material
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). This event is currently under investigation.

 
Event Description

During a tibial angioplasty procedure, the wire got stuck due to the aortic arch and it ripped the exchange port of the delivery catheter. A new advance 14 lp low profile balloon catheter was opened and used to complete the procedure. A section of the device did not remain inside the patient's body. According to the initial reporter, the patient did not require any additional procedures nor experience any adverse effects due to this occurrence.

 
Manufacturer Narrative

(b)(4). Investigation - evaluation: a review of the complaint history, drawings, device history record, documentation, manufacturing instructions and quality control was conducted during the investigation. The complaint device was not returned therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed. There is no evidence to suggest the product was not made to specifications. Review of device history record shows no nonconforming events which could contribute to this failure mode. It should be noted there were no other reported complaints for this lot number. Tensile testing is performed during the manufacturing process. It is likely that excess force contributed to this failure mode, however, without objective evidence, the root cause of this failure mode is unknown. Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined. We will continue to monitor for similar complaints. Per the risk assessment no further action is required.

 
Event Description

During a tibial angioplasty procedure, the wire got stuck due to the aortic arch and it ripped the exchange port of the delivery catheter. A new advance 14 lp low profile balloon catheter was opened and used to complete the procedure. A section of the device did not remain inside the patient's body. According to the initial reporter, the patient did not require any additional procedures nor experience any adverse effects due to this occurrence.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameADVANCE 14 LP LOW PROFILE BALLOON CATHETER
Type of DeviceLIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
rita harden
750 daniels way
bloomington , IN 47402
8003462686
MDR Report Key5868147
Report Number1820334-2016-00649
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/14/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/11/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue NumberPTAX4-14-170-4-4
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 Received07/14/2016
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured03/12/2015
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-