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

Model Number	M00547300
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon 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
It was reported to boston scientific corporation that an extractor pro rx-s retrieval balloon device was used in the pancreas during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, it was noted that the tip of the balloon broke off in the pancreas of the patient.Reportedly, there was an attempt to retrieve the detached tip using another balloon but was unsuccessful.The procedure was then completed with the second extractor pro rx-s retrieval balloon.There have been no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that an extractor pro rx-s retrieval balloon device was used in the pancreas during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, it was noted that the tip of the balloon broke off in the pancreas of the patient.Reportedly, there was an attempt to retrieve the detached tip using another balloon but was unsuccessful.The procedure was then completed with the second extractor pro rx-s retrieval balloon.There have been no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: problem code 2907 captures the reportable event of distal tip detached.Block h10: investigation results: a visual examination of the returned complaint device found that the distal tip including the balloon was detached from the catheter.The detached portion of the device was not returned.It was noticed that the distal end of the rx channel was torn.This failure is likely due to factors such as: handling of the device, the technique used by the physician and normal procedural difficulties encountered during the procedure could have resulted in the failure reported.Therefore, the most probable root cause is adverse event related to procedure.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.

• 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: 9687794
• Report Number: 3005099803-2020-00262
• Device Sequence Number: 3341686
• Product Code: FGE
• UDI-Device Identifier: 08714729907138
• UDI-Public: 08714729907138
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K102082
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2020

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: 10/22/2021
• Device Model Number: M00547300
• Device Catalogue Number: 4730
• Device Lot Number: 0024648193
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2020
• Initial Date Received by Manufacturer: 01/15/2020
• Supplement Date Received by Manufacturer: 04/16/2020
• Initial Report FDA Received Date: 02/10/2020
• Supplement Report FDA Received Date: 05/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1