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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER URETERAL CATHETER; CATHETER, URETHRAL
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BOSTON SCIENTIFIC - SPENCER URETERAL CATHETER; CATHETER, URETHRAL Back to Search Results
Model Number M0064002111
Device Problem Detachment Of Device Component (1104)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/13/2014
Event Type  Injury  
Event Description
It was reported to boston scientific corporation that a cone tip ureteral catheter was used during a retrograde pyelogram procedure performed on (b)(6) 2014.According to the complainant, during the procedure, the tip of the catheter was detached inside the patient and was fully retrieved using a basket.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.
 
Manufacturer Narrative
The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.It was reported the device was not used past its expiry date.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
A visual assessment on the returned cone tip ureteral catheter was performed and it was noted that the cone tip was detached from the distal end of the catheter.The connector was returned and it was not on the catheter when received.Examination under magnification revealed scrape marks at the end of distal end of the catheter and the proximal end of the detached tip.The material was flexed and did not appear to be brittle as it did not break.A review of the device history record could not be performed since the lot number was not provided in the complaint.A labeling review was performed and no anomalies were found.Therefore, taking into consideration these factors and the analysis performed in the device returned, the most probable root cause is ¿operational/physiological context¿.
 
Event Description
It was reported to boston scientific corporation that a cone tip ureteral catheter was used during a retrograde pyelogram procedure performed on (b)(6) 2014.According to the complainant, during the procedure, the tip of the catheter was detached inside the patient and was fully retrieved using a basket.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.
 
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Brand Name
URETERAL CATHETER
Type of Device
CATHETER, URETHRAL
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
ingrid matte
100 boston scientific way
marlborough, MA 01752
5086834000
MDR Report Key3837878
MDR Text Key21726954
Report Number3005099803-2014-02103
Device Sequence Number1
Product Code GBM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K830840
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 05/14/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/29/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM0064002111
Device Catalogue Number400-211
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/15/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/25/2014
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
Patient Outcome(s) Required Intervention;
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