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

Model Number 4FC12

Device Problems Air Leak (1008); Fluid/Blood Leak (1250)

Patient Problems Embolism (1829); Low Blood Pressure/ Hypotension (1914); ST Segment Elevation (2059)

Event Date 06/16/2017

Event Type  Injury  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during a cryo ablation procedure, after the pulmonary vein (pv) was isolated, a competitor mapping catheter was inserted into the sheath.St elevation was then observed and the blood pressure decreased.It was confirmed that an additional sheath was inserted that was a competitor product.Additionally, an embolism was confirmed by angiography and the sheath was flushed.Air ingress was then observed and air would continuously leak.The sheath was flushed with a salt solution and it was confirmed that the embolism resolved.The blood pressure then returned to normal.The case was completed with cryo.No further patient complications have been reported as a result of this event.It was further reported that the patient was intubated post procedure, which is the facility¿s normal process; however, a children¿s tracheal tube was used rather than an adult tube.The patient was discharged without further complications.

Manufacturer Narrative

Event summary: the patient data files are not available for this product.This is a clinical issue encountered during the procedure.No product malfunction reported.Upon visual inspection of flexcath sheath 4fc12 / 96601-033, results showed the device was intact with no apparent issues.Air aspiration was reproduced when a test arctic front catheter was introduced through the sheath.Dissection showed the hemostatic valve was leaking; valve was torn.The sheath failed the test due to leaking homeostatic valve.In conclusion, the reported issue (air ingress) has been confirmed through testing.The reported clinical issues (st-elevation, embolism, bp) were not confirmed through the testing.The sheath failed the returned product inspection due to a leaking hemostatic valve.If information is provided in the future, a supplemental report will be issued.

• 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: 6699862
• MDR Text Key: 79568589
• Report Number: 3002648230-2017-00312
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 08/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2017
• 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: 96601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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