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

Model Number 4FC12

Device Problems Air Leak (1008); Fluid 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

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.

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.

• 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: 105782752
• 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

• 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

• 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

Was the Report Sent to FDA?

• Event Location: No Information
• 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 Treatment Data

Date Received: 07/10/2017 Patient Sequence Number: 1