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U.S. Department of Health and Human Services

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

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MEDTRONIC MEXICO PACIFIC XTREME CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number PCU060300130
Device Problems Deflation Problem (1149); Fracture (1260); Detachment of Device or Device Component (2907)
Patient Problems Fistula (1862); Vascular Dissection (3160)
Event Date 11/09/2020
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 pta balloon catheter along with non-medtronic 7fr sheath and 0. 014" 300cm guidewire during procedure to treat a little calcified plaque lesion in the mid to distal popliteal artery. The vessel diameter and lesion length are 6mm and 100mm respectively. A medtronic inflation device was used for balloon inflation. Inflation fluid used was a contrast 30% and saline70% solution. There was no damage noted to packaging. There was no issue noted when removing device from hoop/tray. The device was prepped per ifu with no issues identified. Balloon deflation difficulties was reported. The deflation issue was noted during subsequent inflation. During withdrawal back into sheath, the catheter broke and the detached piece was removed with a snare. The device passed through a previously deployed stent. No resistance was encountered when advancing the device. More balloons and stents were needed to complete the procedure as a result of the balloon issue. It was reported that the balloon was used to pre dilate the lesion before stenting with a 6mm non-medtronic stent, then also used to post dilate the stent. After the post dilation inflation, the balloon would not deflate. The physician debated puncturing the balloon with a needle percutaneously in order to deflate the balloon, but before that was done, it was noticed that with steady gentle traction against the sheath tip, the balloon was slowing deflating. It was during this process that the catheter shaft broke. Physician snared the retained piece of the balloon and catheter. After snaring, it was noticed that the distal end of the stent was now deformed and a dissection had extended through the popliteal to the tibial/popliteal trunk (tpt) arteries. Multiple balloon inflations and additional stenting was performed to help correct this and improve flow. The patient also developed an av fistula in the tpt. This was relatively slow flow initially but increased quite dramatically over the following 24 hours and ultimately had to be repaired with a covered stent the day after index procedure. Physician reported that the issue with this balloon caused a cascade of additional work that needed to be performed on the patient. A dissection of the popliteal and tpt arteries that require further intervention and stenting. Patient injury of vessel damage and dissection occurred.
 
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Brand NamePACIFIC XTREME
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 
EI  
091708734
MDR Report Key10866197
MDR Text Key217090934
Report Number9612164-2020-04470
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K103464
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/19/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPCU060300130
Device Catalogue NumberPCU060300130
Device Lot Number220526894
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/08/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/24/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/07/2020
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: 11/19/2020 Patient Sequence Number: 1
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