• 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 MICRO ¿ 14 ULTRA LOW-PROFILE PTA 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 MICRO ¿ 14 ULTRA LOW-PROFILE PTA BALLOON CATHETER LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number G26119
Device Problems Material Separation; Stretched
Event Date 04/16/2019
Event Type  Malfunction  
Manufacturer Narrative

Occupation = unknown. Investigation - evaluation: reviews of the complaint history, device history record, drawing, instructions for use (ifu), manufacturer¿s instructions, quality control, and specifications of the device were 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. A review of the device history record shows 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 manufactures instructions and quality control procedures were conducted, and no gaps were discovered. Moreover, an ifu is provided with the device, which states to ¿flush the catheter lumen labeled "distal" using heparinized saline solution. Apply negative pressure to lumen labeled "balloon" prior to introduction. Advance the balloon dilation catheter counter-clockwise over a pre-positioned. 014 inch (0. 36 mm) wire guide. Activate the hydrophilic coating by wiping the balloon with heparinized saline solution. Under fluoroscopy, advance the balloon to the lesion site. Carefully position the balloon across the lesion using both the distal ad proximal radiopaque balloon markers. Note: if resistance is met while advancing the balloon dilation catheter, determine the cause and proceed with caution. " based on the information provided and no product returned, investigation has concluded that a 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 reported, during a renal angiogram involving a (b)(6) patient with renal stenosis, an advance micro ¿ 14 ultra low-profile pta balloon catheter elongated and separated. The device was reported to be flushed with 20 milliliters of saline and another manufacturer's 0. 014 inch guide wire was "wiped down". An unknown manufacturer's sheath was utilized during the case. The physician attempted to advance the complaint device over the wire and noted resistance upon advancement. The physician then decided to remove the device over the wire. During removal of the balloon from the wire, the device "tore". Elongation/stretching was noted prior to the device separating into "3 or 4 pieces". The device did not enter the patient's body. No further intervention was required once the balloon was removed from the wire. The device was disposed of by the customer and the procedure was completed successfully with another device of the same type. As reported, the physician "stated that she felt that she might not have hydrated it enough". 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.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameADVANCE MICRO ¿ 14 ULTRA LOW-PROFILE PTA 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 Key8557887
Report Number1820334-2019-00885
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,USER F
Reporter Occupation
Type of Report Initial
Report Date 04/26/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/26/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberG26119
Device Catalogue NumberPTA3-14-90-2-2
Device LOT Number8157008
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/26/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/21/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-