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 Bacterial Infection (1735); Death (1802)

Event Type  Death  

Manufacturer Narrative

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

Event Description

It was reported that two weeks post cryo ablation procedure, the patient returned to the hospital with a systemic infection and was critically ill.Blood cultures showed the infection was a skin based bacteria.It is unknown how the patient became infected during the procedure, although the physician suspected it may be related to the patient prep.It was later reported that the patient died.Further information received indicated that the physician noted that bacteria was possibly introduced to the patient during insertion of the product during the procedure.No further information is available at this time.

Manufacturer Narrative

Event summary: the patient data files showed at least twelve applications were performed with catheter 2af284/ 34418 on the date of the event without any issue.In conclusion, this is a clinical issue (death, bacterial infection) which occurred two weeks post procedure.There is no indication of relation of adverse event to the performance of the cryo device.If information is provided in the future, a supplemental report will be issued.

Event Description

Incoming information indicate that the access site was closed with a competitor device.The patient was found to have a vegetation on the mitral valve.It was noted that a possible cause of death was embolization of the mitral valve.Further incoming information indicated that prior to the death, the patient was admitted due to back pain and fever.The patient went into septic shock leading to the vegetation on the mitral valve.

Manufacturer Narrative

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

Event Description

Further information received indicated the bacteria was identified to be (b)(6).The patient's blood culture that was (b)(6) in 2 out of 2 bottles.

• 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: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 8162344
• MDR Text Key: 130271363
• Report Number: 3002648230-2018-00938
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2018
• 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
• Date Manufacturer Received: 01/27/2020
• 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: 2AF284 BALLOON CATHETER, 990063-020 MAPPING CATH
• Patient Outcome(s): Death; Hospitalization