MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC (IRWINDALE) COOLFLOW® TUBING SET; CATHETER, ELECTRODE RECORDING

Model Number D-1233-01-S

Device Problems Device Contamination with Chemical or Other Material (2944); Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/03/2015

Event Type  malfunction  

Event Description

It was reported that prior to a procedure, when the coolflow tubing was removed from the package, it was noticed that there was a yellow handwritten memo on the sterile bag.In addition, a black particle is also seen in the tubing.The case was completed with another tubing set without any patient consequence.

Manufacturer Narrative

(b)(4).The device history record (dhr) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.(b)(4).

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.(b)(4).

Manufacturer Narrative

(b)(4).It was reported that prior to a procedure, when the coolflow tubing was removed from the package, it was noticed that there was a yellow handwritten memo on the sterile bag.In addition, a black particle is also seen in the tubing.The case was completed with another tubing set without any patient consequence.Upon visual inspection, yellow handwritten note was stuck to package.Also a small black particle was found embedded inside the tubing.It was confirmed that the yellow memo was created by biosense webster employee during the inspection of the tubings.Ftir of the black particle was performed.Report concludes the black particle as unreacted monomer or plasticizers.The device history record (dhr) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.Complaint was confirmed.

• Brand Name: COOLFLOW® TUBING SET
• Type of Device: CATHETER, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER, INC (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer (Section G): BIOSENSE WEBSTER, INC (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer Contact: jaime chavez ; 9098398483
• MDR Report Key: 4639357
• MDR Text Key: 20364999
• Report Number: 2029046-2015-00067
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P990071/S5
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D-1233-01-S
• Device Catalogue Number: CFT001
• Device Lot Number: OEM_D-1233-01-S
• Other Device ID Number: (01)10846835000016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1