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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 PCU050300130
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Anaphylactic Shock (1703); Low Blood Pressure/ Hypotension (1914)
Event Date 12/10/2020
Event Type  Injury  
Manufacturer Narrative

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

 
Event Description

Physician used pacific xtreme pta balloon to treat a chronic total occlusion (cto-100%) lesion in the left superficial femoral artery (sfa). The lesion length was 10cm. 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 issue identified. It was reported that the device was used to balloon angioplasty the left sfa. When the balloon was deflated, patient's blood pressure dropped to zero and chest compressions were reportedly performed. Dopamine was provided on site. It was postulated that patient had an allergic/anaphylactic reaction to the device. Patient had a history of this happening once before during a previous intervention on the contralateral side (right side) at an unknown date. At that time, it was postulated that it may have been due to medication or having a possible latex allergy. During intervention, fentanyl was not used and physician carefully monitored vitals every step of the way as reported. The patient reportedly recovered on site with patient's blood pressure at 80/40. No further injury reported.

 
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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 Key11035269
MDR Text Key222269525
Report Number9612164-2020-04973
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK103464
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,Followup
Report Date 03/18/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/18/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberPCU050300130
Device Catalogue NumberPCU050300130
Device LOT Number220143576
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 Received03/18/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured06/02/2020
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: 12/18/2020 Patient Sequence Number: 1
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