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

Model Number	M00556021
Medical Device Problem Code	Material Too Rigid or Stiff (1544)
Health Effect - Clinical Codes	Death (1802); Inflammation (1932)
Date of Event	10/01/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
(date of event): date of event was approximated to (b)(6) 2019 as no event date was reported.The complainant was unable to report the batch/lot number; manufacture date, and expiration date are unknown.(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 endoscopic retrograde cholangiopancreatography (ercp) procedure.The procedure date is unknown.According to the complainant, the patient got severe pancreatitis right after the procedure and died.Reportedly, the guidewire was too stiff and caused trauma to the pancreas.The cause of patient's death was unavailable.There were other co-morbidities that possibly led to the event; however, it was not specified.

• 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: 9369201
• Report Number: 3005099803-2019-05724
• Device Sequence Number: 14097929
• Product Code: EZB
• UDI-Device Identifier: 08714729648451
• UDI-Public: 08714729648451
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/25/2019

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00556021
• Device Catalogue Number: 5602
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/05/2019
• Initial Report FDA Received Date: 11/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death