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	09/14/2020
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
It was reported to boston scientific corporation that an extractor pro rx-s retrieval balloon device was used in the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2020.According to the complainant, when the device was withdrawn from the patient, it was noticed that the tip of the catheter detached into the scope.Reportedly, the scope was then removed from the patient and the detached tip was pushed out of the working channel using a rat tooth forceps.The procedure was completed at this time.There were 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 common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6), 2020.According to the complainant, when the device was withdrawn from the patient, it was noticed that the tip of the catheter detached into the scope.Reportedly, the scope was then removed from the patient and the detached tip was pushed out of the working channel using a rat tooth forceps.The procedure was completed at this time.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: device code 2907 captures the reportable event of distal tip detached.Block h10: investigation results a visual examination of the returned complaint device found the balloon was ruptured at the proximal section near the c-channel.It was also noticed that the c-channel of the catheter was ripped.The tip of the catheter was noted still attached to the catheter, thereby the reported event of 'tip detachment' was not confirmed.Based on the analysis performed and the information provided, is possible that factors or conditions related to the procedure during the use of the device, such as the manner in which the device was handled and manipulated and the amount of strength applied by the customer during the movement of the guidewire, could have caused the rupture found on the balloon and the damage noted on the catheter lumen.However, as the device showed no evidence of the alleged issue, the most probable root cause for the reported complaint event of "tip detachment" is no problem detected since the device complaint/problem cannot be confirmed.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: 10662264
• Report Number: 3005099803-2020-04408
• Device Sequence Number: 14524178
• Product Code: FGE
• UDI-Device Identifier: 08714729907138
• UDI-Public: 08714729907138
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 11/16/2020

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: 07/06/2022
• Device Model Number: M00547300
• Device Catalogue Number: 4730
• Device Lot Number: 0025672465
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2020
• Initial Date Received by Manufacturer: 09/14/2020
• Supplement Date Received by Manufacturer: 10/20/2020
• Initial Report FDA Received Date: 10/12/2020
• Supplement Report FDA Received Date: 11/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1