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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MEXICO PACIFIC PLUS CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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MEDTRONIC MEXICO PACIFIC PLUS CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Catalog Number PCE040080130
Device Problems Kinked; Difficult to Remove
Event Date 11/06/2017
Event Type  Malfunction  
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

The physician was attempting to use a pacific plus pta balloon device to treat a plaque lesion with moderate calcification in the mid popliteal artery and popliteal trunk. The vessel was moderately tortuous and had 60% stenosis. It was reported that during balloon delivery on a non-medtronic guidewire, resistance was felt halfway. The physician attempted to advance the balloon a bit further by exerting slightly more force to the catheter and the catheter shaft kinked. No excessive force was used. Reportedly, balloon catheter was stuck with the guidewire and was withdrawn together with wire out of patient's body. The wire was withdrawn from balloon catheter.

 
Manufacturer Narrative

Additional information: the guidewire was flushed and had been wiped down by wet gauze prior to use. The guidewire used was an. 018" non-medtronic guidewire. No patient injury was reported. Device evaluation summary: the device was returned for analysis. The lot of the device was consistent with the information provided in the complaint form. Traces of blood were found on the catheter however the balloon was still folded (also without the red protection). There were 2 kinked point on the shaft: the proximal one at 10 mm from the hub and the distal one at 90 mm. Even if there was a kink on the shaft it was possible to load the 0. 018" guide wire. If information is provided in the future, a supplemental report will be issued.

 
Manufacturer Narrative

Additional information: the lesion length was 65-70mm. The artery diameter was 4 mm. The procedure used a 6 fr sheath. The vessel was not pre-dilated. The procedure was completed using a non-medtronic balloon. If information is provided in the future, a supplemental report will be issued.

 
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Brand NamePACIFIC PLUS
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
MEDTRONIC MEXICO
avenida paseo del cucapah #105
parque industrial el lago
tijuana,bc 22570
MX  22570
Manufacturer (Section G)
MEDTRONIC MEXICO
avenida paseo del cucapah #105
parque industrial el lago
tijuana,bc 22570
MX  22570
Manufacturer Contact
toni o'doherty
parkmore business park west
galway  
091708734
MDR Report Key7085159
Report Number9612164-2017-01718
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/18/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/05/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberPCE040080130
Device LOT Number213393521
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/08/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/10/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/29/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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