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

Model Number 4FC12

Device Problem Insufficient Information (3190)

Patient Problem Pseudoaneurysm (2605)

Event Date 01/01/2016

Event Type  Injury  

Manufacturer Narrative

Medtronic cryocath was made aware of this event through a search of literature publications.It was not possible to ascertain specific device information from the literature publication or to match the event with previously reported events.This information is based entirely on journal literature.This event occurred outside the us.All information provided is included in this report.Patient information is limited due to confidentiality concerns.Multiple patients were referenced in the article.The baseline characteristics of the patients referenced in the article is gender/age is male/(b)(6) years old.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.Referenced article: evaluation of the achieve mapping catheter in cryoablation for atrial fibrillation: a prospective randomized trial.J.Intervent.Card.Electrophysiol.2016;45(2):179-187.(b)(4).

Event Description

Gang y, gonna h, domenichini g, et al.Evaluation of the achieve mapping catheter in cryoablation for atrial fibrillation: a prospective randomized trial.J.Intervent.Card.Electrophysiol.2016;45(2):179-187.Purpose: the purpose of this study is to establish the role of achieve mapping catheter in cryoablation for paroxysmal atrial fibrillation (paf) in a randomized trial.Methods: a total of 102 patients undergoing their first ablation for paf were randomized at 2:1 to an achieve- or lasso-guided procedure.Study patients were systematically followed up for 12 months with holter monitoring.Primary study endpoint was acute procedure success.Secondary endpoint was clinical outcomes assessed by af free at 6 and 12 months after the procedure.Results: of 102 participants, 99 % of acute procedure success was achieved.Significantly shorter procedure duration with the achieve guided group than with the lasso-guided group (118 ± 18 vs.129 ± 21 min, p <(><<)> 0.05) was observed as was the duration of fluoroscopy (17 ± 5 vs.20 ± 7 min, p <(><<)> 0.05) by subgroup analysis focused on procedures performed by experienced operators.In the whole study patients, procedure and fluoroscopic durations were similar in the achieve- (n = 68) and lasso-guided groups (n = 34).Transient phrenic nerve weakening was equally prevalent with the achieve and lasso.No association was found between clinical outcomes and the mapping catheter used.The use of second generation cryoballoon (n = 68) reduced procedure time significantly compared to the first-generation balloon (n = 34); more patients were free of af in the former than the latter group during follow-up.Conclusions: the use of the achieve mapping catheter can reduce procedure and fluoroscopic durations compared with lasso catheters in cryoablation for paf after operators gained sufficient experience.The type of mapping catheter used does not affect procedure efficiency and safety by models of cryoballoon.The literature publication reported the following patient complications: there were two (2) patients who experienced pseudo-aneurysms; which required a thrombin injections.No further patient complications have been reported as a result of this event.

• Brand Name: FLEXCATH STEERABLE SHEATH
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): MEDTRONIC CRYOCATH LP; 16771 chemin ste-marie; kirkland H9H 5 H3; CA H9H 5H3
• Manufacturer (Section G): MEDTRONIC CARDIAC RHYTHM HEART FAILURE; 8200 coral sea st ne; mounds view MN 55112
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 5511827
• MDR Text Key: 40775616
• Report Number: 3002648230-2016-00097
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K081049
• 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: 03/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2016
• 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): Required Intervention
• Patient Age: 00062 YR