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

Model Number	M00547000
Medical Device Problem Codes	Inflation Problem (1310); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has been received for analysis; however, the analysis has not yet been completed.Upon completion of the problem 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 common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2022.During the procedure, the physician asked to put the balloon to 9mm; however, the balloon was not inflated when the balloon was pulled out of duct.Prior to reinserting back into duct the balloon was inflated and deflated a couple of times, the balloon did inflate but did not stay up at 9mm, only 12mm.Additionally, the balloon shape and size was noted to be odd and not rounded, the one side was under-inflated and did not look like it was inflated all the way to 12mm.The balloon was then removed from the duct, the stopcock was opened but the balloon did not automatically deflate and the syringe plunger had to be physically pulled back.The procedure was completed with another extractor pro xl retrieval balloon.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that an extractor pro xl retrieval balloon was used in the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2022.During the procedure, the physician asked to put the balloon to 9mm; however, the balloon was not inflated when the balloon was pulled out of duct.Prior to reinserting back into duct the balloon was inflated and deflated a couple of times, the balloon did inflate but did not stay up at 9mm, only 12mm.Additionally, the balloon shape and size was noted to be odd and not rounded, the one side was under-inflated and did not look like it was inflated all the way to 12mm.The balloon was then removed from the duct, the stopcock was opened but the balloon did not automatically deflate and the syringe plunger had to be physically pulled back.The procedure was completed with another extractor pro xl retrieval balloon.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: device code a0406 captures the reportable event of the balloon irregular shape.Block h10: investigation results a visual examination of the returned complaint device found that the balloon and the catheter of the device had no damages, which does not confirm the reported event of balloon irregular shape.Microscopic inspection was done and found the guidewire channel of the device was ripped.Functional evaluation was performed, the device was inflated with air, the balloon was inflated without problem, no damages were found and the device works properly.The returned device review showed no evidence of either the alleged (or any problem which could have contributed to the event.Therefore, the most probable root cause for this complaint is no problem detected.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 instructions for use (ifu)/product label.

• Brand Name: EXTRACTOR PRO RX
• 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: 14147932
• Report Number: 3005099803-2022-02106
• Device Sequence Number: 2946165
• Product Code: FGE
• UDI-Device Identifier: 08714729790266
• UDI-Public: 08714729790266
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2022

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: 12/17/2023
• Device Model Number: M00547000
• Device Catalogue Number: 4700
• Device Lot Number: 0028576291
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/24/2022
• Supplement Date Received by Manufacturer: 04/21/2022
• Initial Report FDA Received Date: 04/19/2022
• Supplement Report FDA Received Date: 05/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/17/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown