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

Model Number	M00547110
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter facility name: (b)(6).(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, 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 bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, it was noted that the balloon could not be deflated.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 h2: additional information: block e1 (initial reporter's facility name, address and city), block e2 (initial reporter's email), block h10 (additional mfr narrative).Problem code 1149 captures the reportable issue of balloon failed to deflate.Conclusion code 4316 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the device has not been received for analysis.If any further relevant information is received, 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 bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, it was noted that the balloon could not be deflated.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: problem code 1149 captures the reportable issue of balloon failed to deflate.Block h10: investigation result: visual examination of the returned complaint device found the balloon and the catheter of the device had no damages noted.It was also noted that the device was inflated and deflated without problem, which does not confirm the reported event.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.Based on the available information and that the complaint device was able to inflate and deflate successfully, 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 xl retrieval balloon was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, it was noted that the balloon could not be deflated.The procedure was completed with another extractor pro xl retrieval balloon.There were no patient complications reported as a result of this event.

• 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: 10251007
• Report Number: 3005099803-2020-02595
• Device Sequence Number: 16813974
• Product Code: FGE
• UDI-Device Identifier: 08714729790402
• UDI-Public: 08714729790402
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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,Followup
• Report Date (Section B): 12/23/2020

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: 11/06/2021
• Device Model Number: M00547110
• Device Catalogue Number: 4711
• Device Lot Number: 0024727602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2020
• Initial Date Received by Manufacturer: 06/11/2020
• Supplement Date Received by Manufacturer: 08/13/2020; 12/02/2020
• Initial Report FDA Received Date: 07/09/2020
• Supplement Report FDA Received Date: 09/08/2020; 12/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1