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

Model Number	M00547310
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant was unable to report the lot number; therefore, the manufacture date and expiration date 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 medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that the an extractor pro rx retrieval balloon was used during a procedure performed on (b)(6) 2022.During the procedure, it was noticed that the catheter on which the balloon is mounted has failed.The balloon was attempted to be taken out; however, it was impossible to take it out as if something was stuck.There was no erector set up when the balloon was removed.The procedure was completed with another extractor pro rx retrieval balloon.There were no patient complications have been reported due to this event.
Additional Manufacturer Narrative
The complainant was unable to report the lot number; therefore, the manufacture date and expiration date are unknown.Device code a0401 captures the reportable event of catheter break.Block h10: investigation results the returned extractor pro rx retrieval balloon was analyzed and a visual examination found that the catheter of the device was found stretched and detached.No damages were noted to the balloon portion of the device.Microscopic inspection was performed and the catheter was found to be stretched and detached.With all the available information, boston scientific concludes the reported event of catheter break was confirmed.The catheter was stretched and detached which occurred likely due to the manner in which the device was handled and manipulated.Excessive manipulation of the device without enough care, excessive force during handling or usage, and/or forcing the device against significant resistance could induce device damages or loss of functionality.Therefore, the most probable root cause is adverse event related to procedure.A review of the manufacturing documentation for this device was unable to be performed as the lot number is unknown.However, a ship history review was performed to identify the most probable lot numbers and a manufacturing review of the most probable lot numbers did not identify any anomalies or deviations that could have contributed to the event.A labeling review was performed and from the information available, this device was used per the instructions for use (ifu)/product label.
Event or Problem Description
It was reported to boston scientific corporation that the an extractor pro rx retrieval balloon was used during a procedure performed on (b)(6), 2022.During the procedure, it was noticed that the catheter on which the balloon is mounted has failed.The balloon was attempted to be taken out; however, it was impossible to take it out as if something was stuck.There was no erector set up when the balloon was removed.The procedure was completed with another extractor pro rx retrieval balloon.There were no patient complications have been reported due to this 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
• 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: 14934500
• Report Number: 3005099803-2022-03553
• Device Sequence Number: 17600347
• Product Code: FGE
• UDI-Device Identifier: 08714729907152
• UDI-Public: 08714729907152
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 09/22/2022

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 Model Number: M00547310
• Device Catalogue Number: 4731
• 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: 06/10/2022
• Supplement Date Received by Manufacturer: 09/01/2022
• Initial Report FDA Received Date: 07/06/2022
• Supplement Report FDA Received Date: 09/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown