MAUDE Adverse Event Report: ACCESS POINT TECHNOLOGIES EP INC. MAP-IT DIAGNOSTIC MAPPING CATHETER; DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER

Model Number 901670

Device Problem Difficult to Remove (1528)

Patient Problem No Code Available (3191)

Event Date 07/14/2020

Event Type  malfunction  

Manufacturer Narrative

Partial device was returned for evaluation.The handle had been cut off and was disposed of at the facility and was not returned.The catheter (minus the handle) was not able to be analyzed based on the complaint that the curve was locked and would not straighten.The cause could not be confirmed.Review of the device history record revealed the device had been manufactured in accordance with documented specifications and procedures.Medwatch report is late due to difficulties setting up webtrader production account.

Event Description

In the middle of case, the curve locked and could not be straightened out even though the user moved it in many ways.The handle was cut off and a long sheath was placed to remove the catheter.There were no patient consequences reported.

• Brand Name: MAP-IT DIAGNOSTIC MAPPING CATHETER
• Type of Device: DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER
• Manufacturer (Section D): ACCESS POINT TECHNOLOGIES EP INC.; 12560 fletcher lane; suite 300; rogers,
• Manufacturer (Section G): ACCESS POINT TECHNOLOGIES EP INC.; 12560 fletcher lane; suite 300; rogers, mn
• Manufacturer Contact: charlotte gasperlin ; 12560 fletcher lane; suite 300; rogers, mn ; 4329004104
• MDR Report Key: 10420161
• MDR Text Key: 204408773
• Report Number: 3005402529-2020-00018
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 00818087020220
• UDI-Public: 00818087020220
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K160390
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/06/2023
• Device Model Number: 901670
• Device Catalogue Number: 901670
• Device Lot Number: D20021407E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/15/2020
• Initial Date FDA Received: 08/18/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2020
• 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