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 Pain (1994); Vascular System (Circulation), Impaired (2572); Pseudoaneurysm (2605)

Event Date 02/24/2018

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-operatively to a cryo ablation procedure, a pseudoaneurysm of the left groin was observed through sonography.Also, the patient experienced pain at the puncture site.A thrombin injection was administered.The hospital stay was extended.The case was completed with cryo.It was later that the patient was re-admitted to the hospital for pseudoaneurysm of the left groin again.The issue resolved the next day.This patient was a participant in the cryo af global registry clinical study.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Event summary: the patient data files showed at least seven applications were performed with catheter 2af284/ 81446 without any issue on the date of the event.It was reported that post-operatively to a cryo ablation procedure, a pseudoaneurysm of the left groin was observed through sonography.The patient was re-admitted to the hospital for pseudoaneurysm of the left groin again.The issue resolved the next day.The patient experienced pain at the puncture site.The sheath was not returned for investigation.There is no indication that the reported adverse event is related to manufacturing.In conclusion, this is a case related to clinical adverse events (left groin pseudoaneurysm, pain).The reported issue was not related to the performance of the cryoablation devices.The sheath was not returned for investigation.If information is provided in the future, a supplemental report will be issued.

Event Description

(b)(6) 2018: upon further review, it should have been noted that the patient experienced pain at the puncture site.Additionally, the patient was apart of cryo af global registry clinical study.

• 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: 7637668
• MDR Text Key: 112314855
• Report Number: 3002648230-2018-00433
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Type of Report: Initial,Followup
• Report Date: 08/16/2018

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: 01/12/2020
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 42350
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/04/2018
• Initial Date FDA Received: 06/26/2018
• Supplement Dates Manufacturer Received: 07/24/2018
• Supplement Dates FDA Received: 08/16/2018
• Date Device Manufactured: 01/15/2018
• 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: 76 YR
• Patient Weight: 65