MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION IRRIGATION; CATHETER, UROLOGICAL

Model Number M0067201010

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 07/06/2022

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a single action pumping system was to be used during a procedure performed on (b)(6) 2022.Prior to unpacking, it was noticed that a small reddish brown spots were attached to the entire circumference of the spike part or the inside of the spike cap.The procedure was completed with another single action pumping system.There were no patient complications reported as a result of this event.

Manufacturer Narrative

This event was reported by the distributor.The health care facility is: (b)(6).(b)(4).The device has not been received for analysis.Upon receipt and completion of the device analysis, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that a single action pumping system was to be used during a procedure performed on (b)(6) 2022.Prior to unpacking, it was noticed that a small reddish brown spots were attached to the entire circumference of the spike part or the inside of the spike cap.The procedure was completed with another single action pumping system.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h2: additional information: block e1 (initial reporter's facility name, address 1, address 2, city, zip/post code, phone and fax number) and block h10 (additional mfr narrative).Block h6: medical device code a180104 captures the reportable event of foreign material present on the device.Block h10: the device has not been received for analysis.Upon receipt and completion of the device analysis, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Manufacturer Narrative

Block h6: medical device code a180104 captures the reportable event of foreign material present on the device.Block h10: investigation result the returned single action pumping system was analyzed, and a visual evaluation noted that the syringe was not attached to the dual check valve luer lock.The roller clamp was returned in an open position and the tubing set was free from obvious kinks.The device was returned under good condition without evidence of damages; however, some foreign materials were observed in the cap of the spike.No other problems with the device were noted.The reported event of foreign material present on the device was confirmed.Investigation found some foreign materials in the cap of the spike which can be traced to the manufacturing process as a contributing factor.Therefore, the most probable root cause of this event is manufacturing deficiency as the reported event was traced to the manufacturing process.An investigation to address this problem is in progress.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

Event Description

It was reported to boston scientific corporation that a single action pumping system was to be used during a procedure performed on (b)(6) 2022.Prior to unpacking, it was noticed that a small reddish brown spots were attached to the entire circumference of the spike part or the inside of the spike cap.The procedure was completed with another single action pumping system.There were no patient complications reported as a result of this event.

• Brand Name: IRRIGATION
• Type of Device: CATHETER, UROLOGICAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15120907
• MDR Text Key: 304424018
• Report Number: 3005099803-2022-03979
• Device Sequence Number: 1
• Product Code: KQT
• UDI-Device Identifier: 08714729752998
• UDI-Public: 08714729752998
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K870557
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M0067201010
• Device Catalogue Number: 720-101S
• Device Lot Number: 0027077888
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/02/2021
• 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