• 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 G50317
Device Problem Material Puncture / Hole
Event Date 06/18/2019
Event Type  Malfunction  
Manufacturer Narrative

Occupation = non-healthcare professional. Pma/510(k) number = k170193. Investigation ¿ evaluation. Reviews of the complaint history, device history record, drawing, instructions for use (ifu), manufacturer¿s instructions, quality control procedures, and a functional test & visual inspection of the returned device were conducted during the investigation. The visual inspection of the returned package confirmed that the complaint device returned for investigation is consistent with the photos of the complaint device previously provided. Functional testing of the balloon lumen revealed a pinhole rupture between the proximal balloon bond and proximal marker band - in the shoulder area of the balloon. No other damage on the device was noted. Additionally, a document based investigation evaluation was performed. There is no evidence to suggest the product was not made to specifications. A review of the device history record showed no nonconforming events which could contribute to this failure mode. It should also be noted there were no other reported complaints for this lot number. Furthermore, reviews of the manufacturer¿s instructions, drawings, and quality control procedures were conducted, and no gaps were discovered. Moreover, an ifu is provided with this device which notes that the intended use outlines that the device is for percutaneous transluminal angioplasty (pta) of lesions in peripheral arteries, including iliac, renal, popliteal, infrapopliteal, femoral and iliofemoral, as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae. It is noted in bold that particular care should be taken in handling the balloon to prevent damage. The warning section states to not exceed the rated burst pressure and is reiterated on the product packaging. The product labeling provides adequate instructions to properly handle the balloon catheter. ¿in the event that balloon pressure is lost and/or balloon rupture occurs, the balloon is to be deflated and removed with the sheath as a unit. ¿ based on the information provided and the examination of the returned product, investigation has concluded that a root cause for this event could not be established. We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event. Per the quality engineering risk assessment no further action is required.

 
Event Description

As originally reported, during balloon dilation of the anterior tibial artery, involving a (b)(6) year-old male patient, an advance 14 lp low profile balloon catheter would not inflate past 2 atmospheres. No damage was observed on initial inspection of the device. After flushing, the user advanced the balloon catheter over a pre-positioned cook 0. 014 inch wire guide. Per the initial reporter, "negative pressure could only apply to 2 atm/bar" and blood velocity increased under digital subtraction angiography (dsa). The balloon and unknown sheath were removed as a unit and a new cook device was used to complete the procedure successfully. Additional information stated that the customer did not notice any obvious leaks on the device. Another manufacturer's pressure pump with pressure indicator was used to inflate the device, using an unknown contrast agent. The physician clarified that it was difficult to apply pressure/inflate beyond 2 atmospheres. No calcification, angulation, or tortuosity was reported. Upon return and initial investigation of the device, a pinhole rupture was found. 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. Provided these details, this event is not considered reportable. Upon return of the device to the manufacturer, and inspection of the device on 16jul2019 however, a "pinhole leak" was observed just proximal to the proximal marker band.

 
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 (Section G)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
larry pool
750 daniels way
bloomington , IN 47404
8123392235
MDR Report Key8832754
Report Number1820334-2019-01814
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type DISTRIBUTOR,FOREIGN,OTHER
Reporter Occupation
Type of Report Initial
Report Date 07/26/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/26/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberG50317
Device Catalogue NumberPTAX4-14-170-2-12
Device LOT Number9538102
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/27/2019
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/16/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/20/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-