MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION METRIQ IRRIGATION TUBING SET; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number 86447

Device Problem Device Contaminated During Manufacture or Shipping (2969)

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

Event Date 03/08/2023

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

The metriq irrigation tubing set was selected for use during a radiofrequency catheter ablation to treat atrial fibrillation.It was reported that during preparation a foreign material which appeared to be a hair or fiber was observed on the device, therefore, it was not used.The set was replaced with a new one from the same model.The procedure was completed successfully without patient complications.The device has been discarded by the facility.

• Brand Name: METRIQ IRRIGATION TUBING SET
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): AVAIL MEDICAL PRODUCTS INCORPORATED; 6201 america center drive; san jose CA 95002
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 16673442
• MDR Text Key: 312601519
• Report Number: 2124215-2023-12395
• Device Sequence Number: 1
• Product Code: OAD
• UDI-Device Identifier: 08714729862208
• UDI-Public: 08714729862208
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P150005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: 86447
• Device Catalogue Number: 86447
• Device Lot Number: 0060398073
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2022
• 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