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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 PCE050120130
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Intimal Dissection (1333)
Event Date 08/18/2020
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Physician used a pacific plus balloon for vessel pre dilation during a procedure to treat the mid to distal superficial femoral artery (sfa). The vessel was not severely calcified. There was no damage to device package. There was no issue noted when removing device from hoop/tray. The device was prepped per ifu with no issues identified. It is reported that a dissection was found after pre-dilation, so the physician used everflex entrust 6 150mm for stenting. The implant of the stent was not planned as part of the procedure. It is also reported that deployment issue of partial deployment occurred. There was no damage to deployment mechanisms or device handle prior to deployment issue. The thumbscrew/ lock-pin was checked for securement prior to procedure. The lock-pin was removed before stent deployment. The device did not pass through a previously deployed stent. There was no resistance felt while advancing the device. The stent was deployed smoothly at the beginning. When the stent was deployed around 80-90mm, the feedback of thumbscrew became abnormal, at the same time the outer sheath could not be pulled back and the stent could not be released. The physician slightly pulled back the whole delivery system and the rest of the stent was elongated. The target lesion was fully covered by the deployed elongated stent. The length of the deployed stent is 6. 0mm in diameter and 150mm in length. There was no vessel damage caused by the stent. There was no further patient injury reported.
 
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Brand NamePACIFIC PLUS
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
MEDTRONIC MEXICO
av. paseo del cucapah #10510
tijuana,bc 22570
MX 22570
Manufacturer (Section G)
MEDTRONIC MEXICO
av. paseo del cucapah #10510
tijuana,bc 22570
MX 22570
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
091708734
MDR Report Key10546169
MDR Text Key207309202
Report Number9612164-2020-03493
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
K123358
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/17/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/16/2020
Device Catalogue NumberPCE050120130
Device Lot Number214421767
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/16/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/16/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/17/2020 Patient Sequence Number: 1
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