MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number 87035

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/01/2019

Event Type  malfunction  

Event Description

It was reported that undeployment failure occurred.During a mapping procedure in the left atrium with a intellamap orion high resolution mapping catheter the physician noticed the catheter could not come back to its undeployed state.The catheter was easily deployed to the maximum diameter balloon form but it could not return to its original flat state unless the sheath was advanced on it.The procedure was completed with another catheter.No patient complications were reported and the patients current condition is fine.

Manufacturer Narrative

The reported failure was not confirmed through analysis.The device passed all relevant testing/inspection.Based on all available information, no further actions are considered necessary.

Event Description

It was reported that undeployment failure occurred.During a mapping procedure in the left atrium with a intellamap orion high resolution mapping catheter the physician noticed the catheter could not come back to its undeployed state.The catheter was easily deployed to the maximum diameter balloon form but it could not return to its original flat state unless the sheath was advanced on it.The procedure was completed with another catheter.No patient complications were reported and the patients current condition is fine.

• Brand Name: INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 8337064
• MDR Text Key: 136112971
• Report Number: 2134265-2019-01251
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 08714729841968
• UDI-Public: 08714729841968
• Combination Product (y/n): N
• PMA/PMN Number: K143481
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/28/2019

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: 07/19/2019
• Device Model Number: 87035
• Device Catalogue Number: 87035
• Device Lot Number: 22400345
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2019
• Initial Date Manufacturer Received: 02/01/2019
• Initial Date FDA Received: 02/13/2019
• Supplement Dates Manufacturer Received: 03/27/2019
• Supplement Dates FDA Received: 03/28/2019
• Patient Sequence Number: 1