MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTERJECT CLEAR; BIOPSY NEEDLE

Model Number M00518310

Device Problems Failure to Prime (1492); Failure to Advance (2524)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/13/2019

Event Type  malfunction  

Event Description

During upper gi endoscopy, the interject needle would not come out and epinephrine would not go through.Second needle worked without problem.Surgeon never had this happen before.2 rns could not get needle to prime or come out of sheath.Manufacturer response for injection therapy needle, interject clear 25 gauge (per site reporter).Equipment failure reported to endosurgery complaints

• Brand Name: INTERJECT CLEAR
• Type of Device: BIOPSY NEEDLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 100 boston scientific way; marlborough MA 01752
• MDR Report Key: 8944468
• MDR Text Key: 155965532
• Report Number: 8944468
• Device Sequence Number: 1
• Product Code: FCG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/26/2019,07/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00518310
• Device Catalogue Number: M00518310
• Device Lot Number: 23424362
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/26/2019
• Date Report to Manufacturer: 08/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 23360 DA
• Patient Weight: 107