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

Model Number	38260
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Codes	Diminished Pulse Pressure (2606); Paresthesia (4421); Thrombosis/Thrombus (4440)
Date of Event	05/19/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that there was a hole in the catheter.An imager ii angiographic catheter was selected for use in a diagnostic procedure.The patient was being treated for stenosis in the leg.During the procedure, after the second or third injection of km at 1000psi and 15ml/sec, a shaft hole was observed in the middle of the catheter.The procedure was cancelled as a result of this event.Shortly after the procedure, the patient noticed a tingling sensation in their forearm with no pulse.Examination revealed thrombosis in the forearm.The thrombosis was removed mechanically, and a patch was sutured.The patient was well post procedure.The physician suspects that the withdrawal of the catheter may have injured the vessel wall and caused the thrombosis.
Event or Problem Description
It was reported that there was a hole in the catheter.An imager ii angiographic catheter was selected for use in a diagnostic procedure.The patient was being treated for stenosis in the leg.During the procedure, after the second or third injection of km at 1000psi and 15ml/sec, a shaft hole was observed in the middle of the catheter.The procedure was cancelled as a result of this event.Shortly after the procedure, the patient noticed a tingling sensation in their forearm with no pulse.Examination revealed thrombosis in the forearm.The thrombosis was removed mechanically, and a patch was sutured.The patient was well post procedure.The physician suspects that the withdrawal of the catheter may have injured the vessel wall and caused the thrombosis.
Additional Manufacturer Narrative
Device eval by manufacturer: upon receipt at our post market quality assurance laboratory, this imager ii angiographic catheter was examined.Visual inspection showed damage in the form of a rupture approximately 51 cm from the distal end.A kink just distal to the rupture was found.A bend on the catheter was seen 11 cm to 12 cm from the distal end.Inspection of the remainder of the device, apart from the noted damage, revealed no other damage.

• Brand Name: IMAGER II ANGIOGRAPHIC CATHETER
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• MDR Report Key: 11996889
• Report Number: 2134265-2021-06960
• Device Sequence Number: 11015180
• Product Code: DQO
• UDI-Device Identifier: 08714729355755
• UDI-Public: 08714729355755
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2021

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: 06/04/2021
• Device Model Number: 38260
• Device Catalogue Number: 38260
• Device Lot Number: 0000142070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2021
• Initial Date Received by Manufacturer: 05/19/2021
• Supplement Date Received by Manufacturer: 07/01/2021
• Initial Report FDA Received Date: 06/14/2021
• Supplement Report FDA Received Date: 07/27/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR