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

Model Number 2ACH20

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226)

Event Date 04/23/2024

Event Type  Injury  

Event Description

It was reported that during a cryo ablation procedure, the patient became hypotensive.The heart shadow pulse disappeared after observation via imaging.A cardiac tamponade was then confirmed via imaging.The cardiac tamponade was treated.The case was aborted the patient was not under general anesthesia. no further patient complications have been reported as a result of this event.

Manufacturer Narrative

Continuation of d10: product id afapro28 ; product type: balloon catheter; product id 4fc12; product type: sheath.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Additional information was received that the heart beat was obscured by the liquid and no "obvious" beat could be observed.Pericardialcentesis was performed successfully.

Manufacturer Narrative

Updated h6 imf (annex f) health impact.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

It was reported that during a cryoablation procedure, the patient became hypotensive.The heart shadow pulse disappeared after observation via imaging.A cardiac tamponade was then confirmed via imaging.The cardiac tamponade was treated.The case was aborted the patient was not under general anesthesia. no further patient complications have been reported as a result of this event.2024-05-06, additional information was received that the heart beat was obscured by the liquid and no obious beat could be observed.Pericardialcentesis was performed successfully.

Manufacturer Narrative

Product event summary: the 2ach20 mapping catheter with lot number 8834567 was returned and analyzed.Visual inspection of the mapping catheter showed that the device was intact with no apparent issues.No kinks were observed along with the shaft, pebax or tip/loop section.The functional test was performed using a multimeter.The mapping catheter was connected to the test cable.The continuity and impedance measurement between the electrodes and the other side of the cable were normal.No defects were identified.In conclusion, the reported cardiac tamponade occurred during the procedure with no indication that the adverse event was related to the performance or a malfunction of the product and the sheath passed the returned product inspection.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: ACHIEVE ADVANCE MAPPING CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECT
• 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: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 19190255
• MDR Text Key: 341119121
• Report Number: 2182208-2024-01818
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K162892
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/23/2024

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: 8834567
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/23/2024
• Initial Date FDA Received: 04/26/2024
• Supplement Dates Manufacturer Received: 05/01/2024; 05/23/2024
• Supplement Dates FDA Received: 05/06/2024; 05/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/04/2024
• 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): Required Intervention; Life Threatening
• Patient Age: 67 YR
• Patient Sex: Male