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); Low Blood Pressure/ Hypotension (1914)

Event Date 07/28/2020

Event Type  Death  

Manufacturer Narrative

Product event summary: the data files were returned and analyzed.The files showed at least five applications were performed with balloon catheter afapro28 with lot number 38648 without any issue on the date of the event.Clinical issues(hypotension and patient death) occurred following the procedure.In conclusion, the mapping catheter was not returned for investigation.There is no indication of relation of the adverse event to the performance of the product.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that after a successful cryoablation procedure, the patient was stable.It was further reported that a few hours after the procedure the patient's blood pressure dropped.Cardiopulmonary resuscitation was attempted but it was unsuccessful and the patient passed away.

• 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: 10413742
• MDR Text Key: 203125230
• Report Number: 2182208-2020-01533
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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
• Report Date: 08/17/2020

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: 07/29/2020
• Initial Date FDA Received: 08/17/2020
• 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
• Treatment: AFAPRO28 BALLOON CATHETER, 4FC12 SHEATH
• Patient Outcome(s): Death