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

Model Number	M00547040
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant was unable to provide the lot number.Therefore, the manufacture and expiration dates 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 mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an extractor pro rx retrieval balloon was used in the common bile duct (cbd) during a stone removal procedure performed on (b)(6) 2020.According to the complainant, prior to the procedure, it was noticed that a trace of water-like substance was inside the balloon.There was an attempt to inflate and deflate the balloon; however, the balloon could not be deflated and instead continued to inflate.Additionally, it was noted that the physician might have accidentally inflated the balloon with saline instead of air before using it.The procedure was completed with another extractor pro rx retrieval balloon.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: problem code 1149 captures the reportable event of balloon failed to deflate.Block h10: investigation results visual examination of the returned complaint device revealed no visual defects and looked normal.No damage was found on the catheter of the device.Functional analysis was performed, and the balloon was inflated normally.There were no leaks, holes or pinholes noted in the balloon.It was also noted that the balloon was able to deflate without any problem.The balloon outer diameter was measured at its two recommended volumes and were found to be within specifications.The returned device review (visual, physical, and performance testing) showed no evidence of either the alleged or any defect which could have contributed to the event.Therefore, the most probable root cause for this complaint cannot be detected.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.
Event or Problem Description
It was reported to boston scientific corporation that an extractor pro rx retrieval balloon was used in the common bile duct (cbd) during a stone removal procedure performed on (b)(6), 2020.According to the complainant, prior to the procedure, it was noticed that a trace of water-like substance was inside the balloon.There was an attempt to inflate and deflate the balloon; however, the balloon could not be deflated and instead continued to inflate.Additionally, it was noted that the physician might have accidentally inflated the balloon with saline instead of air before using it.The procedure was completed with another extractor pro rx retrieval balloon.There were no patient complications reported as a result of this event.

• 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: 10164983
• Report Number: 3005099803-2020-02291
• Device Sequence Number: 2400864
• Product Code: FGE
• UDI-Device Identifier: 08714729790273
• UDI-Public: 08714729790273
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 08/11/2020

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: 01/29/2022
• Device Model Number: M00547040
• Device Catalogue Number: 4704
• Device Lot Number: 0025130893
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2020
• Initial Date Received by Manufacturer: 05/22/2020
• Supplement Date Received by Manufacturer: 07/15/2020
• Initial Report FDA Received Date: 06/17/2020
• Supplement Report FDA Received Date: 08/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1