MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RX NEEDLE KNIFE XL; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number	M00545840
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Inflammation (1932); Pancreatitis (4481)
Date of Event	01/01/2009
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The exact date of event was not reported.The retrospective study date january 1, 2009, is used for the estimated date of event between january 2009 and december 2016.The literature article did not provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block e1: initial reporter facility name: (b)(6) hospital, reported here as the name exceeded character limit for designated field.Block g2: literature source journal article: lee y, et al."usefulness and complications of needle knife fistulotomy as a rescue procedure in patients with pancreaticobiliary disease" korean j gastroenterol 2020; https://doi.Org/10.4166/kjg.2020.75.6.341 block h6: imdrf patient code e1021 captures the reportable event of pancreatitis.Imdrf patient code e0506 captures the reportable event of hemorrhage.Imdrf patient code e2326 captures the reportable event of inflammation (hyperamylasemia).
Event or Problem Description
Note: this report pertains to one of three devices mentioned in the literature article.Refer to manufacturer reports # 3005099803-2024-05813 and 3005099803-2024-05814 for the associated device information.Boston scientific became aware of events involving ultratome xl sphincterotomes, fluoro tip ercp catheters, and needle knife papillotomes, through the article, usefulness and complications of needle knife fistulotomy as a rescue procedure in patients with pancreaticobiliary disease, by yong jae lee, et al.Per the article, between january 2009 and december 2016, patients underwent an endoscopic retrograde cholangiopancreatography (ercp) procedure, and the following occurred: mild and moderate pancreatitis, bleeding and hyperamylasemia.Please see the referenced article for full details.

• Brand Name: RX NEEDLE KNIFE XL
• Common Device Name: UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 20679955
• Report Number: 3005099803-2024-05815
• Device Sequence Number: 20632303
• Product Code: KNS
• UDI-Device Identifier: 08714729283799
• UDI-Public: 08714729283799
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K973826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Literature,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/13/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: M00545840
• Device Catalogue Number: 4584
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2024
• Initial Report FDA Received Date: 11/13/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown