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

Model Number 87035

Device Problems Contamination (1120); Packaging Problem (3007)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/03/2023

Event Type  malfunction  

Manufacturer Narrative

It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.

Event Description

It was reported that during preparation for a procedure an intellamap orion high resolution mapping catheter was selected.Upon unboxing the catheter, it was noticed that the sterile packaging was torn near the adhesive seal that likely compromised product sterility.The catheter was not used during the procedure, which was cancelled due to another reason.No patient complications were reported.The device is not expected to be returned for analysis.

Manufacturer Narrative

It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.Correction to h6 impact codes from f26 no health consequences or impact to f27 no patient involvement.

Event Description

It was reported that during preparation for a procedure an intellamap orion high resolution mapping catheter was selected.Upon unboxing the catheter, it was noticed that the sterile packaging was torn near the adhesive seal that likely compromised product sterility.The catheter was not used during the procedure, which was cancelled due to another reason.No patient complications were reported.The device is not expected to be returned for analysis.It was further reported that the compromised sterile packaging was not discovered in preparation for a procedure, but rather during a routine inventory stocking.There was no patient or patient procedure involved.

• Brand Name: INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 18093583
• MDR Text Key: 327650259
• Report Number: 2124215-2023-62502
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 08714729841968
• UDI-Public: 08714729841968
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143481
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/21/2023

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: Other
• Device Model Number: 87035
• Device Catalogue Number: 87035
• Device Lot Number: 0031789118
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/03/2023
• Initial Date FDA Received: 11/08/2023
• Supplement Dates Manufacturer Received: 11/07/2023
• Supplement Dates FDA Received: 11/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1