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

Model Number M00545000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Sepsis (2067)

Event Date 07/29/2015

Event Type  Death  

Manufacturer Narrative

The lot number is not known per the complainant; therefore, the device manufacture and expiration dates cannot be determined.(b)(4).According to the complainant, the device was disposed of and is not available for evaluation.At this time, we are unable to determine the relationship between the device and the cause for this event.If there is any further relevant information received, a supplemental medwatch report will be filed.

Event Description

Note: this report is one of six complaints that pertain to the same event (mfr report # 3005099803-2015-02562, 3005099803-2015-02563, 3005099803-2015-02564, 3005099803-2015-02565, 3005099803-2015-02568, and 3005099803-2015-02573).It was reported to boston scientific corporation that three (3) rx cytology brushes, an advanix biliary stent with naviflex rx delivery system, and an autotome rx sphincterotome was used during an endoscopic retrograde cholangiopancreatography (ercp) with papilotomy, brushing and biliary stent placement procedure on (b)(6) 2015.The indications for this procedure were for "chest pain, elevated lft, suspected choledocholithiasis with markedly dilated bile duct on mrcp." according to the complainant, during the procedure, an autotome rx sphincterotome was used to perform the sphincterotomy.The patient's anatomy was reported to be a dilated or larger duct after the sphincterotomy and balloon (manufacturer unknown) dilation.The olympus ercp scope was placed in a torque position.While attempting to obtain a sample from a noted distal stricture, the physician was trying to move the rx cytology brush in and out of the catheter, and the wire near the handle broke.This occurred with two (2) rx cytology brushes.The broken wire was at the user end of the catheter, outside the patient.A third rx cytology brush was used to complete that portion of the procedure, and there were no issues with this device.An advanix biliary stent was placed using a naviflex rx delivery system.Reportedly, there were no issues with the advanix biliary stent, naviflex rx delivery system, and the autotome rx sphincterotome at the conclusion of the procedure.On (b)(6) 2015, the patient's culture tested positive for e.Coli.On (b)(6) 2015, a no contrast ct was completed for the patient resulting in "no acute abnormality on no contrast ct with no evidence for pancreatitis, bowel obstruction or free air." the patient died on (b)(6) 2015 due to e.Coli sepsis.The cause of the e.Coli sepsis is unknown.

• 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: 5058153
• MDR Text Key: 25097322
• Report Number: 3005099803-2015-02573
• Device Sequence Number: 1
• Product Code: FDX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K930348
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Report Date: 08/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M00545000
• Device Catalogue Number: 4500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Death
• Patient Age: 85 YR