MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DREAMTOME RX 44; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number	M00584060
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
Event or Problem Description
Note: this report pertains to one of the two devices used during the same procedure.Refer to mfr report# 3005099803-2018-60199 for the first dreamtome and mfr report# 3005099803-2018-60204 for the second dreamtome.It was reported to boston scientific corporation that a dreamtome rx 44 was unpacked for an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2018.According to the complainant, during unpacking, it was noticed that there was a cotton-like material on the device.A second dreamtome was unpacked and the same cotton-like material was observed.The  procedure was completed with a third dreamtome rx 44.There were no user injury nor patient complications reported as a result of this event.
Additional Manufacturer Narrative
(device codes): problem code 2944 captures the reportable event of foreign material present in the device.According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
Event or Problem Description
Note: this report pertains to one of the two devices used during the same procedure.Refer to mfr report#: for the first dreamtome and mfr report#: 3005099803-2018-60204 for the second dreamtome.It was reported to boston scientific corporation that a dreamtome rx 44 was unpacked for an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2018.According to the complainant, during unpacking, it was noticed that there was a cotton-like material on the device.A second dreamtome was unpacked and the same cotton-like material was observed.Reportedly, there was no visible damage to the device packaging and the sterile barrier did not appear compromised.The  procedure was completed with a third dreamtome rx 44.There were no user injury nor patient complications reported as a result of this event.

• Brand Name: DREAMTOME RX 44
• Common Device Name: UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 7833406
• Report Number: 3005099803-2018-60199
• Device Sequence Number: 11154849
• Product Code: KNS
• UDI-Device Identifier: 08714729778288
• UDI-Public: 08714729778288
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K013153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/30/2021
• Device Model Number: M00584060
• Device Catalogue Number: 47401
• Device Lot Number: 0022193764
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/02/2018
• Supplement Date Received by Manufacturer: 09/04/2018
• Initial Report FDA Received Date: 08/30/2018
• Supplement Report FDA Received Date: 10/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1