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 Fever (1858); Hematoma (1884); Unspecified Infection (1930); Pain (1994)

Event Date 03/07/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that post cryo ablation procedure, subcutaneous hematoma at the puncture site was noted.Additionally, the patient had a fever, and significant pain.The case was completed with cryo.Medications were administered, and the patient's hospitalization was extended.No further patient complications have been reported as a result of this event.The patient was part of the (b)(6) clinical study.Further information received indicated that the patient was recovered and discharged.

Manufacturer Narrative

Event summary: the patient data files showed at least thirty one applications were performed with catheter 2af284/ 61695-84 without any issue on the date of the event.Clinical adverse event encountered post cryo ablation procedure, subcutaneous hematoma at the puncture site was noted.Additionally, the patient had a fever, and significant pain.The sheath 4fc12/10830 was not returned for investigation.In conclusion, this is a case related to clinical adverse events (hematoma, a fever, and significant pain).The sheath was not returned for investigation.If information is provided in the future, a supplemental report will be issued.

Event Description

On 2018-05-11: information indicated there was pus formation from the puncture site.

Manufacturer Narrative

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

Event Description

On (b)(6) 2018: incoming information indicated that for the infection of the puncture site, wound care was performed, and an antibiotic ointment was prescribed.It was noted that the pus formation/suppuration of the puncture site had resolved.

• 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: 7396687
• MDR Text Key: 104356871
• Report Number: 3002648230-2018-00198
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P100010/S015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/02/2018

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 Expiration Date: 12/08/2019
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 10830
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/09/2018
• Initial Date FDA Received: 04/04/2018
• Supplement Dates Manufacturer Received: 05/11/2018; 06/11/2018
• Supplement Dates FDA Received: 05/24/2018; 07/02/2018
• Date Device Manufactured: 12/08/2017
• 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): Hospitalization; Required Intervention
• Patient Age: 40 YR
• Patient Weight: 73