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

Model Number	M00556071
Medical Device Problem Codes	Difficult to Advance (2920); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A visual examination of the device revealed that the hydra jagwire device was found in good condition without any visual damage.The complaint was not confirmed.After analysis of hydra jagwire device, it was determined that the device did not present any visual damage and outer diameters were within specifications, returned device review includes visual, dimensional and activate the hydrophilic coating evaluations that showed no evidence of the reported issue or any defect that could have contributed to the reported event.Based on the information available and the analysis performed, the investigation conclusion code for the complaint will be documented as no problem detected since the device complaint or problem cannot be confirmed.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
Event or Problem Description
It was reported to boston scientific corporation that hydra jagwire guidewire was used in the applicable during a duodenal stent placement procedure on (b)(6) 2020.According to the complainant, during the procedure, the guidewire would not advance smoothly through the delivery system.The procedure was cancelled.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that hydra jagwire guidewire was used in the duodenum during a duodenal stent placement procedure on (b)(6) 2020.According to the complainant, during the procedure, the guidewire was inserted from the tip of the delivery system; the guidewire would not advance smoothly through the delivery system it got caught around the yellow marker at the proximal end of the hanaro stent and could not be advanced further.When the delivery system was slightly bent the guidewire was able to pass through the delivery system and the delivery system was able to advance towards the target anatomy.During the attempted stent deployment, the handle of the delivery system was pulled and the delivery system was fully deployed.However, the stent was not released from the delivery system and the handle got separated.Reportedly, the procedure was cancelled.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6 (device codes): problem code 3191 is being used to capture the reportable issue of aborted/cancelled procedure.Block h10: a visual examination of the device revealed that the hydra jagwire device was found in good condition without any visual damage.Therefore the difficult to advance cannot be confirmed as no failures were found on the device.After analysis of hydra jagwire device, it was determined that the device did not present any visual damage and outer diameters were within specifications, returned device review includes visual, dimensional and activate the hydrophilic coating evaluations that showed no evidence of the reported issue or any defect that could have contributed to the reported event.Based on the information available and the analysis performed, the investigation conclusion code for the complaint will be documented as no problem detected since the device complaint or problem cannot be confirmed.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

• 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: 10765863
• Report Number: 3005099803-2020-05028
• Device Sequence Number: 14264369
• 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,Followup
• Report Date (Section B): 12/15/2020

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: 05/12/2023
• Device Model Number: M00556071
• Device Catalogue Number: 5607
• Device Lot Number: 0025507880
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2020
• Initial Date Received by Manufacturer: 10/06/2020
• Supplement Date Received by Manufacturer: 11/17/2020
• Initial Report FDA Received Date: 10/30/2020
• Supplement Report FDA Received Date: 12/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1