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

Model Number	901670
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/14/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER
• Manufacturer (Section D): ACCESS POINT TECHNOLOGIES EP INC.; 12560 fletcher lane; suite 300; rogers,
• MDR Report Key: 10420161
• Report Number: 3005402529-2020-00018
• Device Sequence Number: 2452716
• Product Code: DRF
• UDI-Device Identifier: 00818087020220
• UDI-Public: 00818087020220
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K160390
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2020
• Initial Report FDA Received Date: 08/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention