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

Model Number	M00556071
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Internal Organ Perforation (1987)
Date of Event	04/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown at this time.(initial reporter address 1): (b)(6).(evaluation conclusion codes): 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 in the transverse colon during a lower gastrointestinal tract stent placement procedure performed on (b)(6) 2019.According to the complainant, during the procedure, a scope was inserted and reached the target location.Angiography was performed through the scope; however, the opening could not be seen due to stenosis.After that, they tried to cannulate the stenosis using the hydra jagwire guidewire.The physician advanced further the guidewire as he thought that the guidewire was able to penetrate the stenosis.A tandem angiographic catheter was then inserted along with the guidewire wherein angiography was performed in the opening side of the stenosis.The physician, although it was not certain, he believed that it was already at the lumen of the colon and then the tandem was removed.A hanarostent was then inserted along with the guidewire, then it was positioned, and the stent was deployed.After the procedure was completed, the patient complained of abdominal pain.A computed tomography was performed and showed that the colon stent was deployed in the abdominal cavity.According to the physician, it seemed that it perforated when guidewire was advanced in the abdominal cavity.Reportedly, the surgery department was consulted and an emergency operation was performed.There was no malfunction of the guidewire that attributed to the perforation.In addition, it was also confirmed that there was no malfunction reported with the hanarostent and the tandem.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.

• 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: 8628530
• Report Number: 3005099803-2019-02600
• Device Sequence Number: 19375408
• Product Code: EZB
• UDI-Device Identifier: 08714729648505
• UDI-Public: 08714729648505
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• 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
• Report Date (Section B): 05/21/2019

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?: No
• Operator of Device: Health Professional
• Device Model Number: M00556071
• Device Catalogue Number: 5607
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2019
• Initial Report FDA Received Date: 05/21/2019
• 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: Other
• Patient Age: 85 YR