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

Model Number M00584060

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/02/2018

Event Type  malfunction  

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 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.

Manufacturer Narrative

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 Description

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.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
• Type of Device: UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 7833404
• MDR Text Key: 118880792
• Report Number: 3005099803-2018-60204
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 08714729778288
• UDI-Public: 08714729778288
• Combination Product (y/n): N
• PMA/PMN Number: K013153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 08/02/2018
• Initial Date FDA Received: 08/30/2018
• Supplement Dates Manufacturer Received: 09/04/2018
• Supplement Dates FDA Received: 10/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1