MAUDE Adverse Event Report: MEDTRONIC, INC. ACHIEVE MAPPING CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number 2ACH20

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

Patient Problems Dyspnea (1816); Pneumothorax (2012)

Event Date 03/06/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the day after a cryo ablation procedure, the patient complained of pain during breathing.A chest x-ray was done and revealed pneumothorax partialis.The patient will be monitored by a cardiac surgeon.The case had been completed with cryo.The patient is a participant in the cryo atrial fibrillation (af) clinical study.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

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

• Brand Name: ACHIEVE MAPPING CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: lisa robertson ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635262723
• MDR Report Key: 8500187
• MDR Text Key: 141483734
• Report Number: 2182208-2019-00680
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• PMA/PMN Number: K162892
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/20/2020
• Device Model Number: 2ACH20
• Device Catalogue Number: 2ACH20
• Device Lot Number: 11050291
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/18/2019
• Initial Date FDA Received: 04/10/2019
• Supplement Dates Manufacturer Received: 04/16/2019
• Supplement Dates FDA Received: 04/16/2019
• Date Device Manufactured: 08/21/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 4FC12 SHEATH
• Patient Outcome(s): Life Threatening; Other
• Patient Age: 63 YR
• Patient Weight: 74