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

Model Number	M00547110
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	04/09/2019
Type of Reportable Event	Serious Injury
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 xl retrieval balloon was used in the choledoch during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the tip of the device caused a perforation in the biliary tract.The tip was noted to be very rigid, though there was no alleged malfunction of the device.No treatment or intervention was performed for the perforation.The procedure was completed with another extractor pro xl retrieval balloon.The patient's condition at the conclusion of the procedure was reported to be stable.
Event or Problem Description
It was reported to boston scientific corporation that an extractor pro xl retrieval balloon was used in the choledoch during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the tip of the device caused a perforation in the biliary tract.The tip was noted to be very rigid, though there was no alleged malfunction of the device.No treatment or intervention was performed for the perforation.The procedure was completed with another extractor pro xl retrieval balloon.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Patient code 2001 captures the reportable issue of perforation.Investigation results: a visual examination of the returned complaint device did not show visual defects and the balloon bonds were inspected and found to be continuous and intact.Additionally, the distal tip of the device was carefully inspected and it looked normal, no deformations nor damages were observed.A functional examination was performed and the balloon was able to be inflated up to its two recommended inflation volumes; there were no leaks, holes, pinholes noted and the balloon was able to hold the pressure.A dimensional examination was performed and the balloon's outer diameter (od) was measured at its two recommended volumes; low and high passed and were within specification.Although there was no alleged malfunction of the device; however, the tip of the device caused a perforation in the biliary tract and perforation is noted within the dfu as a potential adverse events associated with the use of this device.Therefore, the most probable root cause is known inherent risk of device.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.A labeling review was performed and from the information available, this device was used per the directions for use (dfu)/product label.

• Brand Name: EXTRACTOR PRO XL
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8570008
• Report Number: 3005099803-2019-02309
• Device Sequence Number: 1537886
• Product Code: FGE
• UDI-Device Identifier: 08714729790402
• UDI-Public: 08714729790402
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• 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): 06/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/11/2019
• Device Model Number: M00547110
• Device Catalogue Number: 4711
• Device Lot Number: 0021495652
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2019
• Initial Date Received by Manufacturer: 04/09/2019
• Supplement Date Received by Manufacturer: 05/27/2019
• Initial Report FDA Received Date: 05/01/2019
• Supplement Report FDA Received Date: 06/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1