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

Model Number	M00547010
Medical Device Problem Codes	Crack (1135); Stretched (1601); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation results: visual examination of the returned complaint device found that the distal tip of the catheter including the balloon detached and was not returned.It was also noticed that the shaft was cracked and stretched.This failure is likely due to factors encountered during the procedure, such as handling of the device, the technique used by the physician, and normal procedural difficulties encountered during the procedure, that could have affected device performance and its intended purpose.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.
Event or Problem Description
It was reported to boston scientific corporation that an extractor pro rx retrieval balloon was used in the esophagus during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, it was noticed that the balloon got separated from catheter.The balloon was retrieved from the endoscope, and the procedure was completed with another extractor pro rx retrieval balloon.There were no patient complications reported as a result of this event.Investigation results revealed that the distal tip of the catheter detached; 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: 10183452
• Report Number: 3005099803-2020-02304
• Device Sequence Number: 886200
• Product Code: FGE
• UDI-Device Identifier: 08714729790297
• UDI-Public: 08714729790297
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 06/23/2020

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: 11/28/2021
• Device Model Number: M00547010
• Device Catalogue Number: 4701
• Device Lot Number: 0024848797
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/25/2020
• Initial Report FDA Received Date: 06/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1