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	Device Embedded In Tissue or Plaque (3165)
Date of Event	09/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluated by manufacturer: returned product consisted of an imager diagnostic catheter.Visual inspection showed small bends along the shaft.Microscopic inspection revealed that the tip detached approximately 1.5cm from the tip.The tip damage that was noticed was a tensile force damage.The tip end looks to be damaged in a way of stretched and uneven looking surfaces.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.The analysis of the device tip is consistent with the catheter being stuck in another device and tensile force being applied to remove the device.Age at time of event: 18 years or older.
Event or Problem Description
It was reported that the catheter tip detached inside the patient.A 4fr contralateral imager ii angiographic catheter was selected for an inferior vena cava (ivc) filter removal procedure.The 4fr imager was inserted via a jugular approach and a guidewire was fed through the catheter and into the previously implanted filter struts to help dislodge the filter from the ivc wall.During the procedure, when removing the 4fr imager catheter, the catheter tip became caught on the struts of the previously implanted filter and the tip of the 4fr imager catheter broke off and became lodged in the filter.An attempt was made to retrieve the detached tip but this was unsuccessful.There was no attempt to remove the implanted filter, with the detached lodged tip, from the patient.The patient was asymptotic with no complications.

• Brand Name: IMAGER II ANGIOGRAPHIC CATHETER
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• MDR Report Key: 10662567
• Report Number: 2134265-2020-13861
• Device Sequence Number: 11833340
• Product Code: DQO
• UDI-Device Identifier: 08714729355991
• UDI-Public: 08714729355991
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K120893
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/12/2020

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 Expiration Date: 04/08/2022
• Device Model Number: 38260
• Device Catalogue Number: 38260
• Device Lot Number: 0000151319
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/16/2020
• Initial Report FDA Received Date: 10/12/2020
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2020
• 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
• Outcome Attributed to Adverse Event: Other