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

Model Number	M00547010
Medical Device Problem Codes	Break (1069); Burst Container or Vessel (1074); Stretched (1601); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation results: a photo provided by the customer shows the device inside its pouch packaging.A visual examination of the returned complaint device revealed that the catheter detached in two sections.It was also noticed that the catheter was also kinked and stretched.No damage was found on the balloon.It is probable that the physician applied more force than usual during the procedure, causing the catheter to stretch and kink until the material could not support the tension and detached.However, the reported failure of the balloon being burst could not be confirmed.Based on the analysis performed and the information provided, the most probable root cause for the complaint event is no problem detected since the reported device complaint or 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.
Event or Problem Description
It was reported to boston scientific corporation that an extractor pro rx retrieval balloon was used in the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the balloon burst while attempting to be inflated.The procedure was completed with another extractor pro rx retrieval balloon.There have been no patient complications reported as a result of this event.Investigation results revealed that the catheter detached in two sections; therefore, this is now an mdr reportable event.

• Brand Name: EXTRACTOR PRO RX
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10845138
• Report Number: 3005099803-2020-05222
• Device Sequence Number: 3629968
• Product Code: FGE
• UDI-Device Identifier: 08714729790297
• UDI-Public: 08714729790297
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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
• 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: 07/14/2022
• Device Model Number: M00547010
• Device Catalogue Number: 4701
• Device Lot Number: 0025712060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/20/2020
• Initial 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