MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER RX CYTOLOGY BRUSH; ENDOSCOPIC CYTOLOGY BRUSH

Model Number M00545000

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that when the rx cytology brush was received at the hospital a hair was noted inside the sterile packaging.There were no patient complications reported as a result of this event as the device was not used during a procedure.

Manufacturer Narrative

Investigation results.Visual evaluation of the returned rx cytology brush was inside the original sealed pouch.There were no damages found on the pouch; the seal was intact and sterility was not compromised.The generic plastic bag was received sealed.Further evaluation noted that the hair was found between the original product pouch and a generic plastic bag that is applied by the distributor.Therefore, the most probable root cause for this event is determined to be handling damage.A review of the device history record (dhr) was performed and no deviations were found.A search of the complaint database confirmed that no other complaints exist for the specified batch.

Event Description

It was reported to boston scientific corporation that when the rx cytology brush was received at the hospital a hair was noted inside the sterile packaging.There were no patient complications reported as a result of this event as the device was not used during a procedure.

• Brand Name: RX CYTOLOGY BRUSH
• Type of Device: ENDOSCOPIC CYTOLOGY BRUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• Manufacturer (Section G): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 6629571
• MDR Text Key: 77535075
• Report Number: 3005099803-2017-01705
• Device Sequence Number: 1
• Product Code: FDX
• UDI-Device Identifier: 08714729268628
• UDI-Public: (01)08714729268628(17)20190228(10)0020324749
• Combination Product (y/n): N
• PMA/PMN Number: K930348
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/22/2017

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: 02/28/2019
• Device Model Number: M00545000
• Device Catalogue Number: 4500
• Device Lot Number: 0020324749
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/22/2017
• Initial Date FDA Received: 06/09/2017
• Supplement Dates Manufacturer Received: 06/30/2017
• Supplement Dates FDA Received: 07/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2017
• 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