MAUDE Adverse Event Report: MEDTRONIC, INC. CRYOFLEX SURGICAL ABLATION PROBE; SURGICAL DEVICE, FOR ABLATION OF CARDIAC TISSUE

Model Number 60SF2

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Ischemia (1942)

Event Type  Injury  

Event Description

Medtronic received information indicating that during the use of this cryoprobe, the patient developed a coronary spasm related to the cryo-ablation procedure.The spasm was resolved by applying topical papaverine and relaxing the mobilizing table around the left anterior descending artery.Subsequently, ischemic changes were relieved and left ventricular function recovered.There were no adverse patient effects immediately following the procedure.

Event Description

Medtronic received information indicating that following median sternotomy and left anterior descending artery (lad) mobilization, the patient, with premature ventricular contractions (pvc), developed a coronary spasm related to the cryo-ablation procedure.The spasm was resolved by applying topical papaverine and relaxing the mobilizing table around the lad.Subsequently, ischemic changes were relieved and left ventricular function recovered.There were no adverse patient effects immediately following the procedure.Seven days following the procedure rf ablation was performed to resolve the pvcs.

Manufacturer Narrative

The return of the device has been requested, but is not available for return.Without the return of the product, no definitive conclusion can be made regarding the clinical observation.Product identification information has been requested, but has not been made available.Without this information the manufacturing and expiration dates cannot be determined.(b)(4).Journal article source: doi: http://dx.Doi.Org/10.1016/j.Hrthm.2015.02.016.

Manufacturer Narrative

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

• Brand Name: CRYOFLEX SURGICAL ABLATION PROBE
• Type of Device: SURGICAL DEVICE, FOR ABLATION OF CARDIAC TISSUE
• Manufacturer (Section D): MEDTRONIC, INC.; 3800 annapolis lane; minneapolis MN 55447
• Manufacturer (Section G): MEDTRONIC STRUCTURAL HEART; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 4854352
• MDR Text Key: 5848799
• Report Number: 3008592544-2015-00023
• Device Sequence Number: 1
• Product Code: OCL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121878
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,health professional,lit
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 60SF2
• Device Catalogue Number: 60SF2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/20/2015
• Was Device Evaluated by Manufacturer?: No
• 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