MAUDE Adverse Event Report: IMAGER II ANGIOGRAPHIC CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	38260
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the tip was broken.An imager ii angiographic catheter was selected for use in a mesenteric angiogram with intervention.During preparation, the catheter was opened to the sterile field and was flushed with heparinized saline.A tug on the tip with minimal pressure pulled the tip off of the catheter body before insertion into the patient.The procedure was completed with a non-boston scientific catheter.No patient complications were reported.
Additional Manufacturer Narrative
Device eval by manufacturer: returned product consisted of an imager diagnostic catheter in the sterile pouch.The device was examined for damage or any irregularities.The device showed multiple areas of bends due to the packaging being folded up by the customer site for return analysis.The device had multiple bends from shipping.It was noticed inside of the sterile pouch that the tip was separated from the shaft.The catheter shaft and tip were removed from the packaging and the length of the broken tip was approximately 3cm long.Inspection of the remainder of the device, apart from the observed damage revealed no damage or irregularities.The complaint was confirmed for kinks and a broken tip.
Event or Problem Description
It was reported the tip was broken.An imager ii angiographic catheter was selected for use in a mesenteric angiogram with intervention.During preparation, the catheter was opened to the sterile field and was flushed with heparinized saline.A tug on the tip with minimal pressure pulled the tip off of the catheter body before insertion into the patient.The procedure was completed with a non-boston scientific catheter.No patient complications were reported.

• Brand Name: IMAGER II ANGIOGRAPHIC CATHETER
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• MDR Report Key: 11793913
• Report Number: 2134265-2021-05690
• Device Sequence Number: 19813766
• Product Code: DQO
• UDI-Device Identifier: 08714729356004
• UDI-Public: 08714729356004
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K120893
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2021

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: 06/05/2021
• Device Model Number: 38260
• Device Catalogue Number: 38260
• Device Lot Number: 0000142078
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2021
• Initial Date Received by Manufacturer: 04/14/2021
• Supplement Date Received by Manufacturer: 05/26/2021
• Initial Report FDA Received Date: 05/07/2021
• Supplement Report FDA Received Date: 06/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1