MAUDE Adverse Event Report: MEDTRONIC CRYOCATH LP FLEXCATH ADVANCE STEERABLE SHEATH; CATHETER, STEERABLE

Model Number 4FC12

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

Patient Problems Arrhythmia (1721); Low Blood Pressure/ Hypotension (1914)

Event Date 11/12/2020

Event Type  Injury  

Manufacturer Narrative

This information is based entirely on journal literature.Medtronic was made aware of this event through a search of literature publications.This event occurred outside the us.Patient information is limited due to confidentiality concerns.The event only occurred with one patient but specific details on the patient were not provided.The model listed in the report is a representative of the model family, as there is no specific model listed.Without a lot number or device serial number, the manufacturing date cannot be determined.Since no device id was provided, it is unknown if this event has been previously reported.A request for additional information will be made and upon receipt a supplemental report will be submitted accordingly.Referenced article: case report:managing profound circulatory collapse post-atrial fibrillation ablation: a methodical approach.European heart journal - case reports (2020) 4, 1¿5.Doi:10.1093/ehjcr/ytaa324.

Event Description

A journal article was reviewed that contained information regarding cryoballoon ablation.The article reports a patient who experienced transient drops in blood pressure with no change in sinus rate during each pulmonary vein (pv) freeze, which responded well to intravenous (iv) fluids.Immediately post-ablation the patient developed profound recurrent hypotension which responded transientlyto iv fluids.Her physical examination was unremarkable, and her femoral access site appeared fine with no clinical evidence of hematoma.The patient then developed further recurrent profound hypotension responding initially to iv fluids but was associated with the reduced conscious level and metabolic acidosis.The patient was given iv adrenaline and received iv fluids including one unit of packed red cells, protamine iv, and prothrombin complex concentrate to treat a presumed acute bleeding event.An emergency computed tomography (ct) scan of the chest, abdomen, and pelvis with contrast was performed which excluded any bleeding source, esophageal injury, pulmonary embolism, and acute pv occlusion.The patient developed a further hypotensive episode which responded once again to iv fluids.Their electrocardiogram at that time revealed sinus bradycardia with intermittent pauses.An iv bolus of atropine was given and then commenced onto an isoprenaline infusion.After this, the patient stabilized and the isoprenaline infusion was stopped the following day.The status/disposition of the catheter is unknown.No further patient complications have been reported as a result of this event.Further follow up did not yet yield any additional information.

• Brand Name: FLEXCATH ADVANCE STEERABLE SHEATH
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): MEDTRONIC CRYOCATH LP; 9000 autoroute transcanadienne; pointe-claire,qc H9R 5 Z8; CA H9R 5Z8
• Manufacturer (Section G): MEDTRONIC CRYOCATH LP; 9000 autoroute transcanadienne; pointe-claire,qc H9R 5 Z8; CA H9R 5Z8
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 12539864
• MDR Text Key: 273631357
• Report Number: 3002648230-2021-00448
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K123591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/28/2021

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/15/2021
• Initial Date FDA Received: 09/28/2021
• 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
• Patient Age: 76 YR