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

Model Number 990063-020

Device Problems Entrapment of Device (1212); Knotted (1340)

Patient Problems Hemorrhage/Bleeding (1888); Tissue Damage (2104)

Event Date 07/27/2017

Event Type  Injury  

Event Description

It was reported that during a cryo ablation procedure, after ablating the last vein, it was difficult to retrieve the mapping catheter out of the patient's vein.It was noted that more force than usually was necessary to finally retrieve the catheter from the vein.Also, a piece of vein tissue had adhered to the catheter.The patient salivated blood, and noted bleeding from the nose and mouth.To avoid aspiration of blood, the patient was intubated.The intubation was discontinued the following day.The patient was hospitalized for a few days.The case had been completed using cryo.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the mapping catheter, 990063-020 with lot number 213528637 was returned and analyzed.Visual inspection of the catheter showed it was stuck inside the balloon catheter.The loop section was outside the catheter and knotted.Some tissue was adhered to the mapping catheter.In conclusion, the reported issue was confirmed through visual testing.A clinical issue (bleeding from the nose and mouth) was encountered during the procedure.The mapping catheter failed the inspection due to the knotted loop and adhering tissue on the loop.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

Event Description

The mapping catheter subsequently tested out of specification per the manufacturer's investigation.

• 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: 6811656
• MDR Text Key: 83293787
• Report Number: 9612164-2017-01151
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K162892
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/28/2017

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Model Number: 990063-020
• Device Catalogue Number: 990063-020
• Device Lot Number: 213528637
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/28/2017
• Initial Date FDA Received: 08/22/2017
• Supplement Dates Manufacturer Received: 10/02/2017; 10/02/2017
• Supplement Dates FDA Received: 10/02/2017; 10/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2017
• 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): Hospitalization; Required Intervention