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

Model Number	38275
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/10/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the catheter broke.The totally occluded target lesion was located in the calcified left common iliac artery.Access to the lesion was from the right groin.A 4fr imager ii angiograhphic catheter was advanced over a v-18 guidewire.During the procedure, the imager embedded in the chronic total occlusion (cto).The physician tried backing out the device but experienced difficulty due to the cto.The v-18 wire was switched to a different wire to see if this would help.This was not successful.In attempts to pull the imager out from the cto, the imager catheter broke approximately 80mm from the distal end.The broken section was retrieved via snare and no fragments were left in the patient.There were no further patient complications and the patient was fine.It was possible that the device was kinked and broke at this location.
Additional Manufacturer Narrative
Device evaluated by manufacturer: analysis showed that the device was separated approximately 11.5cm from the tip.There were multiple small bends and kinks located throughout the shaft.The catheter looked to be stretched, which would give the indication of tensile force.This damage is consistent with patient conditions such as a severely calcified, stenosed lesion and tortuous anatomy.The reported information stated that the device was imbedded in a total chronic occlusion.Tensile testing was performed on the returned unit by pulling approximately 84cm from the strain relief.Maximum tensile force was 7lbs.The minimum specification is 2.2lbs.This confirms the device met specification.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.
Event or Problem Description
It was reported that the catheter broke.The totally occluded target lesion was located in the calcified left common iliac artery.Access to the lesion was from the right groin.A 4fr imager ii angiographic catheter was advanced over a v-18 guidewire.During the procedure, the imager embedded in the chronic total occlusion (cto).The physician tried backing out the device but experienced difficulty due to the cto.The v-18 wire was switched to a different wire to see if this would help.This was not successful.In attempts to pull the imager out from the cto, the imager catheter broke approximately 80mm from the distal end.The broken section was retrieved via snare and no fragments were left in the patient.There were no further patient complications and the patient was fine.It was possible that the device was kinked and broke at this location.

• Brand Name: IMAGER II ANGIOGRAPHIC CATHETER
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• MDR Report Key: 10452311
• Report Number: 2134265-2020-11600
• Device Sequence Number: 4044715
• Product Code: DQO
• UDI-Device Identifier: 08714729404408
• UDI-Public: 08714729404408
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 10/22/2020

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: 10/15/2021
• Device Model Number: 38275
• Device Catalogue Number: 38275
• Device Lot Number: 0000145905
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2020
• Initial Date Received by Manufacturer: 08/12/2020
• Supplement Date Received by Manufacturer: 09/25/2020
• Initial Report FDA Received Date: 08/25/2020
• Supplement Report FDA Received Date: 10/22/2020
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention