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

Model Number	M00547100
Medical Device Problem Codes	Material Deformation (2976); Material Twisted/Bent (2981); Adverse Event Without Identified Device or Use Problem (2993); Failure to Deflate (4060)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	06/02/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf device code a140101 captures the reportable event of balloon failed to deflate.Patient code e2114 is being used to capture the reportable event of perforation.Impact code f19 is being used to capture the reportable event of surgical intervention.Impact code f08 is being used to capture the reportable event of hospitalization or prolonged hospitalization.
Event or Problem Description
It was reported to boston scientific corporation that an extractor pro xl retrieval balloon was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During the procedure, it was noticed that the balloon did not deflate.The physician used force to try to remove the device from the bile duct.As a result of the struggle, the catheter kinked and the patient was taken to surgery.The physician only had to vacuum the duct and he was able to remove the device easily.In surgery, the physician found a microperforation in the bile duct because bile was noted in the peritoneum.This did not require any suture or additional treatment because it was a very small leak.The patient was noted to have st segment elevation.On (b)(6) 2023, the patient was discharged and fully recovered.
Additional Manufacturer Narrative
Block h6: imdrf device code a140101 captures the reportable event of balloon failed to deflate.Patient code e2114 is being used to capture the reportable event of perforation.Impact code f19 is being used to capture the reportable event of surgical intervention.Impact code f08 is being used to capture the reportable event of hospitalization or prolonged hospitalization.Block h10: investigation results: the returned extractor pro rx retrieval balloon was analyzed, and a visual examination found that the catheter was returned with mechanical cut, smash in one section and kinked.Media analysis was performed, it was observed that the hoop inside the pouch with the label information.However, the device cannot be observed in the picture.Functional examination was not performed due to the condition of the returned device.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of catheter kinked was confirmed.It was found that the catheter was returned with mechanical cut, smash in one section and kinked.E catheter was returned with mechanical cut, smash in one section and kinked.With all the available information, the most probable cause of the reported problem cannot be established.A labeling review was performed and from the information available, this device was used per the directions for use (dfu)/product label.
Event or Problem Description
It was reported to boston scientific corporation that an extractor pro xl retrieval balloon was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During the procedure, it was noticed that the balloon did not deflate.The physician used force to try to remove the device from the bile duct.As a result of the struggle, the catheter kinked and the patient was taken to surgery.The physician only had to vacuum the duct and he was able to remove the device easily.In surgery, the physician found a microperforation in the bile duct because bile was noted in the peritoneum.This did not require any suture or additional treatment because it was a very small leak.The patient was noted to have st segment elevation.On (b)(6) 2023, the patient was discharged and fully recovered.

• Brand Name: EXTRACTOR PRO XL
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; cork business technology park; model farm road; cork ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17398817
• Report Number: 3005099803-2023-04053
• Device Sequence Number: 7556689
• Product Code: FGE
• UDI-Device Identifier: 08714729790389
• UDI-Public: 08714729790389
• Combination Product (Y/N): N
• Initial Reporter Country: PE
• PMA/510(K) Number: K102082
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/06/2024
• Device Model Number: M00547100
• Device Catalogue Number: 4710
• Device Lot Number: 0030665886
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/30/2023
• Supplement Date Received by Manufacturer: 10/13/2023
• Initial Report FDA Received Date: 07/26/2023
• Supplement Report FDA Received Date: 11/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male