MAUDE Adverse Event Report: MEDTRONIC MEXICO AMPHIRION DEEP PTA BALLOON CATHETER CATHETER, PERCUTANEOUS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Sepsis (2067); Heart Failure (2206); Patient Problem/Medical Problem (2688)

Event Date 07/14/2016

Event Type  Death  

Manufacturer Narrative

Date of death: based on date of article publication. Date of event: based on date of article publication journal of endovascular therapy. Sagepub. Com/journalspermissions. Nav. Doi: 10. 1177/1526602816659279 www. Jevt. Org. If information is provided in the future, a supplemental report will be issued.

Event Description

A study was conducted with 36 patients, to investigate the clinical outcomes of endovascular therapy for upper extremity peripheral artery disease with critical hand ischemia. The patients were treated with an amphiprion deep balloon and non-medtronic devices. The 3 patients died within 30 days, during follow-up it was reported that the patients presented with finger amputation, 7 fingers on 5 limbs, 2 limb amputations above the wrist, incomplete wound healing and puncture site problems, 20 patients died 4 with heart failure, 4 with ventricular fibrillation, 3 sudden death, 8 patients died non-cardiovascular 1 sepsis, 4 pneumonia, 3 suffocation and 1 unknown cause.

Manufacturer Narrative

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

• Brand Name: AMPHIRION DEEP PTA BALLOON CATHETER
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC MEXICO; avenida paseo del cucapah #105; parque industrial el lago; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; avenida paseo del cucapah #105; parque industrial el lago; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 7851235
• MDR Text Key: 119380511
• Report Number: 3004066202-2018-00042
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K052791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 12/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• 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: 12/06/2018
• Was Device Evaluated by Manufacturer?: No Answer Provided
• 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: 09/06/2018 Patient Sequence Number: 1