MAUDE Adverse Event Report: MEDTRONIC MEXICO ACHIEVE MAPPING CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number 990063-020

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

Patient Problems Blood Loss (2597); No Code Available (3191)

Event Date 08/27/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that during a cryo ablation procedure, the transeptal puncture was difficult.The sheath was replaced with a competitor sheath.It was noted that there was additional difficulty putting the sheath back in after using the competitor sheath.It was then reported that after the first application, blood was observed.An endotracheal tube was placed and blood was also found in the tube.Incoming information indicated that there was no injury in the heart and the cause of the bleeding from the mouth was unknown.A computerized tomography (ct) scan was performed confirming no injury to the heart.The patient remains in the hospital.The procedure was aborted while the patient was under general anesthesia.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the product was returned and analyzed.Visual inspection of the reported mapping catheter 990063-020 lot number 215196542 showed the device was intact with no apparent issues, and there was no array coagulation.Additionally, the mechanical verification of the steering function was normal.In conclusion, the mapping catheter passed the returned product inspection and there is no sufficient evidence that the catheter caused the clinical issues (bleeding and aborted under general anesthesia).If information is provided in the future, a supplemental report will be issued.

• Brand Name: ACHIEVE MAPPING CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7890594
• MDR Text Key: 120760269
• Report Number: 9612164-2018-02451
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K102588
• 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: 11/08/2018

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: 04/16/2020
• Device Model Number: 990063-020
• Device Catalogue Number: 990063-020
• Device Lot Number: 215196542
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/27/2018
• Initial Date FDA Received: 09/19/2018
• Supplement Dates Manufacturer Received: 10/12/2018
• Supplement Dates FDA Received: 11/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/16/2018
• 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
• Treatment: 4FC12 SHEATH
• Patient Outcome(s): Other
• Patient Age: 70 YR