MAUDE Adverse Event Report: MEDTRONIC, INC. ACHIEVE ADVANCE 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 Death (1802); Great Vessel Perforation (2152); Blood Loss (2597); Pericardial Effusion (3271)

Event Date 06/21/2019

Event Type  Death  

Manufacturer Narrative

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

Event Description

It was reported that the patient was deceased.The physician attempted a couple of freezes in the left superior pulmonary vein (lspv) with no good occlusion.Then, they proceeded to the right inferior pulmonary vein (ripv) and later returned to the lspv.However, there was no time to isolation (tti).Then, another freeze was attempted but there was a sudden pressure drop.An effusion was noted and a pericardiocentesis was done.Additionally, there was a perforation in the lspv.Furthermore, there was a lot of blood which could not be contained.The patient bled out due to a hole or tear in the lspv and passed away.The cause of the perforation was unknown.

Manufacturer Narrative

Product event summary: the data files were returned and analyzed.The data files showed at least 16 applications were performed with balloon catheter 2af284 with lot 66715 without any issue on the date of the event.Data files not able to confirm the clinical issues.The physical product was not returned for investigation.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ACHIEVE ADVANCE 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: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 8843900
• MDR Text Key: 152743022
• Report Number: 2182208-2019-01380
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162892
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/27/2019

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 Model Number: 2ACH20
• Device Catalogue Number: 2ACH20
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/18/2019
• Initial Date FDA Received: 07/30/2019
• Supplement Dates Manufacturer Received: 08/05/2019
• Supplement Dates FDA Received: 08/27/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Death