MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION HYDRA JAGWIRE; STYLET FOR CATHETER, GASTRO-UROLOGY

Model Number	M00556041
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212); Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a hydra jagwire guidewire was used during an eus-directed transgastric ercp (edge) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the physician needed to pass a needle through the remnant stomach to fill with saline and contrast as well as place a boston scientific stent.A hydra jagwire wire was placed through the expect needle, the needle tip peeled the hydrophilic coating on the guidewire.The hydra jagwire ptfe jacket coating peeled and the coating became stuck in the distal end of the needle.Reportedly, the corewire tip broke off inside needle.A new expect needle and hydra jagwire were used to complete the procedure.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.

• Brand Name: HYDRA JAGWIRE
• Common Device Name: STYLET FOR CATHETER, GASTRO-UROLOGY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9256883
• Report Number: 3005099803-2019-05213
• Device Sequence Number: 13913399
• Product Code: EZB
• UDI-Device Identifier: 08714729648475
• UDI-Public: 08714729648475
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/30/2019

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: 09/04/2022
• Device Model Number: M00556041
• Device Catalogue Number: 5604
• Device Lot Number: 0024217221
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/04/2019
• Initial Report FDA Received Date: 10/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1