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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER GENESYS HTA PROCERVA®; DEVICE, THERMAL ABLATION, ENDOMETRIAL
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BOSTON SCIENTIFIC - SPENCER GENESYS HTA PROCERVA®; DEVICE, THERMAL ABLATION, ENDOMETRIAL Back to Search Results
Model Number M006580211
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/23/2015
Event Type  malfunction  
Event Description
It was reported to boston scientific corporation that a genesys hydrothermablation (hta) procerva procedure set was opened for use in a hydrothermablation (hta) procedure on (b)(6) 2015.According to the complainant, during preparation of the procedure, they found a small metal piece inside the plastic packaging of the hta kit.The procedure was completed successfully with another of the same device.The patient's condition at the conclusion of the procedure was reported to be fine.
 
Event Description
It was reported to boston scientific corporation that a genesys hydrothermablation (hta) procerva procedure set was opened for use in a hydrothermablation (hta) procedure on (b)(6) 2015.According to the complainant, during preparation of the procedure, they found a small metal piece inside the plastic packaging of the hta kit.The procedure was completed successfully with another of the same device.The patient's condition at the conclusion of the procedure was reported to be fine.
 
Manufacturer Narrative
(b)(4).The complainant was unable to provide the device lot number; therefore, the lot expiration and device manufacture dates are unknown.It was reported the device was not used past its expiry.The device has been received for analysis.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
 
Manufacturer Narrative
Visual analysis of the returned genesys hta procerva procedure set revealed three small pieces of metal taped to the front plate of the cassette housing.The metal pieces are consistent in appearance with fragments of communication board contacts.The cassette back plate was removed for evaluation.The metal pieces do not appear to be from the cassette communication board that was returned; all of the communication board contacts were present and attached.It was not possible to determine an origin of these metal pieces, these pieces are likely not from that manufacturing environment.Each cassette undergoes extensive inspections prior to packaging.The pieces might have been from the customer¿s location from a previous procedure.Since the origin of the metal pieces cannot be determined; therefore, the most probable root cause is undeterminable.
 
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Brand Name
GENESYS HTA PROCERVA®
Type of Device
DEVICE, THERMAL ABLATION, ENDOMETRIAL
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 Key4624348
MDR Text Key5586800
Report Number3005099803-2015-00600
Device Sequence Number1
Product Code MNB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P000040
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 02/23/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/23/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM006580211
Device Catalogue Number58021
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/05/2015
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/09/2015
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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