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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION DREAMTOME RX 44 UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) Back to Search Results
Model Number M00584040
Device Problems Contamination (1120); Packaging Problem (3007)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/03/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The device has not been received for analysis. Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
 
Event Description
It was reported to boston scientific corporation that a dreamtome rx 44 was intended to be used in the common bile duct (cbd) in an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021. During preparation outside the patient, when the device was unpacked, it was found that the packaging had water damage. Additionally, it was reported that there was not any other visible damage noted to the sterile pouch, seal, or the device itself. The procedure was completed with another of the same device. There were no patient complications reported as a result of this event. Note: photos of the complaint device outside the patient were provided by the customer and showed the device packaging had water damage which had infiltrated into the sterile pouch.
 
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Brand NameDREAMTOME RX 44
Type of DeviceUNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
2546 calle primera
alajuela
CS
Manufacturer Contact
carole morley
300 boston scientific way
marlborough, MA 01752
5086834015
MDR Report Key12908356
MDR Text Key286061575
Report Number3005099803-2021-06338
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K013153
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/13/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/01/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM00584040
Device Catalogue Number8404
Device Lot Number0027584920
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/20/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/22/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/29/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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