MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L. DE CV FLEXCATH ADVANCE STEERABLE SHEATH; CATHETER, STEERABLE

Model Number 4FC12

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)

Event Date 10/27/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant medical product: 990063-020 mapping catheter.Product event summary: the data files were returned and analyzed.The data files showed that system notice 50028 (indicating that there was a problem with the injection process) was received on the date of the event.In conclusion, the clinical issue (pericardial effusion and hypotension) occurred during the procedure.There is no indication of a relation of the adverse events to the performance and malfunction of the product.In conclusion the physical product was not returned for analysis.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during a cryo ablation procedure when the left superior pulmonary vein (lspv) and the left common pulmonary vein (lcpv) were ablated, the esophageal temperature dropped rapidly.The physician attempted to cannulate the right sided veins.The physician returned to the left sided veins and attempted two more ablations where the balloon was inflated and deflated.An effusion was noted.The patient's blood pressure started to decline.Pericardiocentesis was performed and the patient stabilized.The case was aborted and the patient was under general anesthesia.It was reported that the patient was small and had a difficult anatomy.Per the physician, the effusion likely occurred during the cannulation attempts of the right sided veins.It was visualized on fluoroscopy and on a non-medtronic mapping system, that the physician led with the mapping catheter the entire procedure.It was also reported a failure to deliver refrigerant occurred sometime during the procedure.No further patient complications have been reported as a result of this event.

• Brand Name: FLEXCATH ADVANCE STEERABLE SHEATH
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer (Section G): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 13026446
• MDR Text Key: 287613299
• Report Number: 3002648230-2021-00577
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/17/2021

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: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/18/2021
• Initial Date FDA Received: 12/17/2021
• 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
• Patient Outcome(s): Required Intervention; Life Threatening