MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXTRACTOR PRO RX-S; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M00547310
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 or Problem Description
Note: this report pertains to one of two extractor pro rx-s retrieval balloons used during the same procedure.It was reported to boston scientific corporation that the two extractor pro rx-s retrieval balloons were used in the duodenum during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2018.According to the complainant, during the procedure, it was noted that the catheter was severed and was sectioned into two.The same issue occurred with the second extractor pro rx-s retrieval balloon.It was noted that nothing detached into the patient.The procedure was completed with a third extractor pro rx-s retrieval balloon.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Problem code 2907 captures the reportable issue of catheter broken.Investigation result: visual examination of the returned complaint device revealed a kink on the catheter; the catheter was not sectioned into two pieces.The inner radio opaque (ro) markers inside the balloon were inspected for any sharp edge and there were no abnormalities found.It is possible that the failure may be related to the interaction between the balloon and the scope and the handling of the device during the procedure.This failure is likely due to an interaction between the user and device, or sample, which caused or contributed to the error.Therefore, the most probable root cause is unintended use error caused or contributed to event.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.A labeling review was performed and from the information available, this device was used per the directions for use (dfu)/product label.
Event or Problem Description
Note: this report pertains to one of two extractor pro rx-s retrieval balloons used during the same procedure.It was reported to boston scientific corporation that the two extractor pro rx-s retrieval balloons were used in the duodenum during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2018.According to the complainant, during the procedure, it was noted that the catheter was severed and was sectioned into two.The same issue occurred with the second extractor pro rx-s retrieval balloon.It was noted that nothing detached into the patient.The procedure was completed with a third extractor pro rx-s retrieval balloon.There were no patient complications reported as a result of this event.

• Brand Name: EXTRACTOR PRO RX-S
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8217978
• Report Number: 3005099803-2018-62408
• Device Sequence Number: 16542384
• Product Code: FGE
• UDI-Device Identifier: 08714729907152
• UDI-Public: 08714729907152
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K102082
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/16/2020
• Device Model Number: M00547310
• Device Catalogue Number: 48861
• Device Lot Number: 0022387239
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2019
• Initial Date Received by Manufacturer: 12/12/2018
• Supplement Date Received by Manufacturer: 01/23/2019
• Initial Report FDA Received Date: 01/04/2019
• Supplement Report FDA Received Date: 02/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1