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

Model Number	M00547020
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	11/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: date of event was approximated to (b)(6) 2018 as no event date was reported.(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 retrieval balloon device was used in the biliary area during a procedure performed on an unknown date.According to the complainant, prior to the procedure, the balloon was tested outside the duodenoscope and was noted to inflate only at one side.It was also noted that the balloon could not initially be deflated; after several attempts, the balloon deflated.After introducing the device into the scope channel, the same problem occurred again.No patient complications have been reported as a result of this event.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported to boston scientific corporation that an extractor pro rx retrieval balloon device was used in the biliary area during a procedure performed on an unknown date.According to the complainant, prior to the procedure, the balloon was tested outside the duodenoscope and was noted to inflate only at one side.It was also noted that the balloon could not initially be deflated; after several attempts, the balloon deflated.After introducing the device into the scope channel, the same problem occurred again.No patient complications have been reported as a result of this event.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.Additional information received on december 19, 2018.It was reported that the event occurred during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2018.The procedure was completed with another extractor pro rx balloon.There have been no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Problem code 1149 for the reportable issue of balloon failed to deflate.Conclusion code 4316 is being used in lieu of an adequate conclusion code for "device not returned".The complainant indicated that the device will not be returned for investigation.Therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental mdr will be filed.

• 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: 8169217
• Report Number: 3005099803-2018-61952
• Device Sequence Number: 1697128
• Product Code: FGE
• UDI-Device Identifier: 08714729790310
• UDI-Public: 08714729790310
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2019

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 Expiration Date: 06/18/2020
• Device Model Number: M00547020
• Device Catalogue Number: 4702
• Device Lot Number: 0022272489
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/22/2018
• Supplement Date Received by Manufacturer: 12/19/2018
• Initial Report FDA Received Date: 12/17/2018
• Supplement Report FDA Received Date: 01/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1