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 Anemia (1706); No Code Available (3191)

Event Date 02/02/2017

Event Type  Injury  

Event Description

It was reported that after a cryo ablation procedure, when the balloon catheter was manipulated in the left atrium, the patient's transient blood-pressure dropped and the heart rate increased.Noradrenalin, salt solution and vasolan were administered and blood pressure was regained.The healthcare professional noted this may have been due to dehydration.Additionally, bleeding occurred from the inguinal region where the sheath was inserted.When the patient left an operation room, stable cardiohemodynamics were observed.No pericardial effusion was confirmed and the patient responded normally when the physician talked to patient.The patient's four limbs motion was normal.A physician taking care of the patient commented that a vessel near the vein was possibly damaged from the side where the sheath was inserted.The case was completed with cryo.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the data files for the date of the reported event were returned and analyzed; no anomalous flow, pressure or temperature behaviors were recorded.It was also reported that no system notices were recorded.The sheath, 4fc12 with lot 01228, was not returned for investigation.Clinical issues (hematoma and hypotension) occurred during the procedure.In conclusion, the case was related to clinical issues (hematoma and hypotension) and the sheath, 4fc12 with lot 01228, was not returned.

Event Description

Additional information was received via follow up indicating that the physician first noticed bleeding following the insertion of a competitor sheath.The sheath was then replaced with a medtronic sheath but the bleeding continued.Following the procedure a ct scan showed no issues.The patient experienced anemia post procedure but recovered and was discharged.The physician commented that the bleeding was likely caused by two insertion sites in the vein being too close and interfering with each other in the subcutaneous tissue.The insertion angle was approximately forty five degrees.The physician further commented that the space between the two sites should be larger to accommodate the sheath and prevent bleeding, and that the event was likely cause by the insertion site issues rather than the sheath.

Manufacturer Narrative

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

• Brand Name: FLEXCATH ADVANCE STEERABLE SHEATH
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): MEDTRONIC CRYOCATH LP; 9000 autoroute transcanadienne; pointe-claire,qc ; CA
• Manufacturer (Section G): MEDTRONIC CRYOCATH LP; 9000 autoroute transcanadienne; pointe-claire,qc ; CA
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 6356797
• MDR Text Key: 68269523
• Report Number: 3002648230-2017-00093
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K123591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Remedial Action: Inspection
• Type of Report: Initial,Followup,Followup
• Report Date: 03/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/21/2018
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 01228
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2016
• 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): Life Threatening; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 36