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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INVATEC SPA PACIFIC PLUS CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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INVATEC SPA PACIFIC PLUS CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Catalog Number PCE060040090
Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907); Device Damaged by Another Device (2915)
Patient Problem Pain (1994)
Event Date 03/23/2020
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Physician used a pacific xtreme device with a non-medtronic 5f sheath and non-medtronic guidewire during treatment of a lesion in the patient¿s distal left superficial femoral artery (sfa). Lesion exhibited 90% stenosis. Ifu was followed and the device was prepped without issue. Three successful dilations of in stent restenosis were performed with the pacific xtreme balloon. The inflation pressure of the balloon was maintained below rbp. The balloon was completely deflated for removal from the patient without reported issue. When the physician was withdrawing the balloon through the introducer sheath some resistance was noted. The physician injected some contrast and the balloon was further withdrawn and a sudden loss in resistance was noted. The patient then complained about pain in the malleolar region. The balloon is reported to have ruptured and the shaft could not be retrieved on the non-medtronic wire. Angiography showed the balloon outside of the introducer sheath (both markers visible). When the physician pulled back the wire, only the distal marker was observed to have moved into the sheath. The physician then decided to remove the balloon, wire and sheath in tandem, while attempting to keep the detached balloon portion also. Only the distal marker was removed. A 7fr sheath was placed and dilation was performed to reduce resistance using another pacific xtreme device. The balloon fragment continued to migrate distally and became wedged in the stent. The pacific xtreme was placed dismally and partially inflated to pull up the detached balloon piece up close to the sheath. The pacific xtreme was then deflated completely and removed without issue. The physician then advanced a gooseneck snare to try and retrieve the balloon portion unsuccessfully. The guidewire tip is reported to have broken and became caught on the stent but was removed with a gooseneck snare. The guidewire removal attempt caused the damage to the stent resulting in it ¿unknotting¿. An attempt was made to catch the detached piece of balloon with the snare but was unsuccessful. Additional efforts were made to remove the balloon fragment but these were unsuccessful and resulted in stent fracture. The patient was sent to bypass surgery. No further injury reported.
 
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Brand NamePACIFIC PLUS
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
INVATEC SPA
via martiri della liberta, 7
roncadelle 25030
IT 25030
Manufacturer (Section G)
INVATEC SPA
via martiri della liberta, 7
roncadelle 25030
IT 25030
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
091708734
MDR Report Key9877771
MDR Text Key195741063
Report Number3004066202-2020-00014
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeSZ
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,Followup,Followup
Report Date 09/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/25/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/23/2022
Device Catalogue NumberPCE060040090
Device Lot Number1M003362
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/22/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/11/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/24/2019
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: 03/25/2020 Patient Sequence Number: 1
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