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

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.

• Brand Name: PACIFIC XTREME
• Type of Device: CATHETER, 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 Key: 11035269
• MDR Text Key: 222269525
• Report Number: 9612164-2020-04973
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (Y/N): N
• Reporter Country Code: US
• PMA/PMN Number: K103464
• Number of Events Reported: 1
• 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 Received: 12/18/2020
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: HEALTH PROFESSIONAL
• Device MODEL Number: PCU050300130
• Device Catalogue Number: PCU050300130
• Device LOT Number: 220143576
• 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 Received: 03/18/2021
• Was Device Evaluated By Manufacturer?: No Answer Provided
• Date Device Manufactured: 06/02/2020
• 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