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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PERCUFLEX PLUS; CATHETER, BILIARY, DIAGNOSTIC
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BOSTON SCIENTIFIC CORPORATION PERCUFLEX PLUS; CATHETER, BILIARY, DIAGNOSTIC Back to Search Results
Model Number M0061752620
Device Problem Material Deformation (2976)
Patient Problem Perforation (2001)
Event Date 11/08/2018
Event Type  Injury  
Manufacturer Narrative
Date of event was approximated to (b)(6) 2018, as no event date was reported.(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
 
Event Description
It was reported to boston scientific corporation that an implanted percuflex plus stent was explanted during a stent exchange and lithotripsy for stones procedure to be performed in the kidney and ureter.The exact date of this event was not reported.According to the complainant, during stent removal, the physician noticed that the coil of the stent was kinked.Attempts were made to straighten the coil and in the process, the ureter was perforated.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.
 
Event Description
It was reported to boston scientific corporation that an implanted percuflex plus stent was explanted during a stent exchange and lithotripsy for stones procedure to be performed in the kidney and ureter.The exact date of this event was not reported.According to the complainant, during stent removal, the physician noticed that the coil of the stent was kinked.Attempts were made to straighten the coil and in the process, the ureter was perforated.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.Additional information received on 12/05/2018.The date of the event was (b)(6) 2018.The stent was not removed earlier than the scheduled procedure date, and lithotripsy was not able to be performed.After the stent removal a new stent was implanted.There were no patient complications as a result of this event, and the condition of the patient at the conclusion of the procedure was reported to be stable.
 
Manufacturer Narrative
Additional information: date of event updated.Event: updated.Implant and explant dates updated.(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
 
Event Description
It was reported to boston scientific corporation that an implanted percuflex plus stent was explanted during a stent exchange and lithotripsy for stones procedure to be performed in the kidney and ureter.The exact date of this event was not reported.According to the complainant, during stent removal, the physician noticed that the coil of the stent was kinked.Attempts were made to straighten the coil and in the process, the ureter was perforated.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.Additional information received on 12/05/2018.The date of the event was (b)(6) 2018.The stent was not removed earlier than the scheduled procedure date, and lithotripsy was not able to be performed.After the stent removal a new stent was implanted.There were no patient complications as a result of this event, and the condition of the patient at the conclusion of the procedure was reported to be stable.
 
Manufacturer Narrative
Block f10: problem code 2976 captures the reportable event of stent kinked during stent removal.Patient code 2001 captures the reportable event of perforation in ureter.Block h6: conclusion code 4316 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the device was received and product analysis was completed a visual evaluation was performed on the returned device.The proximal section (bladder pigtail) was found to be buckled/accordion, moreover, calcification were found at several locations of the stent.A functional inspection was performed, a mandrel 0.038" was inserted through the stent and resistance was met during its advancing due to the section encountered as buckled/accordion.All compiled information on this investigation determines that the most probable cause for the reported perforation, ureter/urethra and the encountered issue of cause is known inherent risk of device since reported adverse event known and documented in the labeling (including both short or long term known complications or adverse reactions).Based on the product analysis, the device has the working length buckled, however, this failure is known to be generated due to the force used when the stent is pushed up with the pusher/positioner over the guidewire; therefore, it is the most likely that it was generated due to the manipulation of the device or due to the interaction with other devices during the preparation.Therefore, the most probable cause of this complaint is adverse event related to procedure since it is the most likely that the adverse event occurred during the preparation and the device had no influence on event.A review of the device history record (dhr) was performed; no anomalies were found.
 
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Brand Name
PERCUFLEX PLUS
Type of Device
CATHETER, BILIARY, DIAGNOSTIC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key8130924
MDR Text Key129385348
Report Number3005099803-2018-61734
Device Sequence Number1
Product Code FAD
UDI-Device Identifier08714729056829
UDI-Public08714729056829
Combination Product (y/n)N
PMA/PMN Number
K924608
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 08/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/28/2021
Device Model NumberM0061752620
Device Catalogue Number175-262
Device Lot Number0021803540
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/28/2019
Initial Date Manufacturer Received 11/08/2018
Initial Date FDA Received12/04/2018
Supplement Dates Manufacturer Received12/05/2018
07/19/2019
Supplement Dates FDA Received12/28/2018
08/08/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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