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 an rx cytology brush was prepared for use.According to the complainant, during preparation, a foreign material which seemed to be like lint was found inside the sterile packaging of the device.The size was reported to be about 10mm×5mm.There were no patient complications reported as a result of this event.

Manufacturer Narrative

An rx cytology brush was received for analysis.A visual evaluation of the returned device revealed that the original sealed pouch was received inside of a generic plastic bag.It was also noticed that there were no anomalies found on the original sealed pouch; the seal was intact and sterility was not compromised and the generic plastic bag was received sealed.Further evaluation noted that a foreign matter was found in between the original pouch and generic plastic bag.The reported event that a foreign matter was found inside the sterile pouch could not be confirmed; however, the investigation did confirm the reported event that the foreign matter was in between the original pouch and generic plastic bag and sterility was not compromised.It is most likely that the sealed device was packaged on a second layer generic bag at distribution center and the foreign matter was inserted during packaging.Based on all gathered information, the most probable cause of this complaint is ¿manufacturing: distribution process¿.An investigation to address this issue has been completed.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release for distribution.A search of the complaint database revealed that no other complaints exist for the specified lot.

Event Description

It was reported to boston scientific corporation that an rx cytology brush was prepared for use.According to the complainant, during preparation, a foreign material which seemed to be like lint was found inside the sterile packaging of the device.The size was reported to be about 10mm×5mm.There were no patient complications reported as a result of this event.

• 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: 7491128
• MDR Text Key: 107496024
• Report Number: 3005099803-2018-01438
• Device Sequence Number: 1
• Product Code: FDX
• UDI-Device Identifier: 08714729268628
• UDI-Public: 08714729268628
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 04/20/2018

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: 02/20/2020
• Device Model Number: M00545000
• Device Catalogue Number: 4500
• Device Lot Number: 21763338
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/20/2018
• Initial Date FDA Received: 05/07/2018
• Supplement Dates Manufacturer Received: 05/30/2018
• Supplement Dates FDA Received: 06/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/20/2018
• 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