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

Model Number	M00547320
Medical Device Problem Codes	Entrapment of Device (1212); Problem with Sterilization (1596); Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant was unable to provide the lot number.Therefore, the manufacture and expiration dates are unknown.(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 procedures involving one extractor pro balloon.It was reported to boston scientific corporation that an extractor pro rx-s retrieval balloon device was used during a procedure performed on an unknown date.According to the complainant, during the procedure, a part of an extractor device detached and was mistakenly left inside the scope.On (b)(6) 2017, during a separate procedure, a foreign object was noted to be stuck inside the endoscope and blocked the passage.Reportedly, the foreign object found in the scope was the part of an extractor balloon that was used from the previous procedure.There were no patient complications reported as a result of the event.
Additional Manufacturer Narrative
The complainant was unable to provide the lot number.Therefore, the manufacture and expiration dates are unknown.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 procedures involving one extractor pro balloon.It was reported to boston scientific corporation that an extractor pro rx-s retrieval balloon device was used during a procedure performed on an unknown date.According to the complainant, during the procedure, a part of an extractor device detached and was mistakenly left inside the scope.On (b)(6) 2017, during a separate procedure, a foreign object was noted to be stuck inside the endoscope and blocked the passage.Reportedly, the foreign object found in the scope was the part of an extractor balloon that was used from the previous procedure.There were no patient complications reported as a result of the 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: 8147694
• Report Number: 3005099803-2018-61833
• Device Sequence Number: 2069839
• Product Code: FGE
• UDI-Device Identifier: 08714729907176
• UDI-Public: 08714729907176
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2019

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 Model Number: M00547320
• Device Catalogue Number: 48861
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/15/2018
• Supplement Date Received by Manufacturer: 04/17/2019
• Initial Report FDA Received Date: 12/10/2018
• Supplement Report FDA Received Date: 05/13/2019
• Patient Sequence Number: 1