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

Model Number M00545000

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/21/2014

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that an rx cytology brush was used in the pancreatic duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2014.According to the complainant, the brush was unable to retract back into the sheath when functional test was performed.Since resistance was encountered when manipulating the device, they extended and retracted the brush several times.The brush gradually bent from the strong resistance.The procedure was not completed because the same device is unavailable.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be good.

Manufacturer Narrative

Reported complaint of brush bent.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.

Manufacturer Narrative

Investigation results: visual evaluation of the returned product found no anomalies.There were no kinks and bends present in the working length.The brush was not bent.Functional evaluation found the device to extend and retract with no issue.The distance between the proximal end of the groove at the tip of the extrusion and the distal tip of the bristle was within specification.Measurement of the outer extrusion as well as brush extension meets specification.The complaint was not confirmed; the brush was not bent, and there were no issues during retraction.The returned device showed neither evidence of the alleged issues, nor any defect which could have contributed to the event.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to 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 used in the pancreatic duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2014.According to the complainant, the brush was unable to retract back into the sheath when functional test was performed.Since resistance was encountered when manipulating the device, they extended and retracted the brush several times.The brush gradually bent from the strong resistance.The procedure was not completed because the same device is unavailable.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be good.

• 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: ingrid matte ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 3678776
• MDR Text Key: 4294043
• Report Number: 3005099803-2014-01369
• Device Sequence Number: 1
• Product Code: FDX
• Combination Product (y/n): N
• PMA/PMN Number: K930348
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/21/2014

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: Nurse
• Device Expiration Date: 08/09/2015
• Device Model Number: M00545000
• Device Catalogue Number: 4500
• Device Lot Number: 16297616
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/13/2014
• Initial Date FDA Received: 03/14/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/02/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/14/2013
• 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