MAUDE Adverse Event Report: IRVINE BIOMEDICAL, INC. INQUIRY¿; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number IBI-81531

Device Problems Bent (1059); Difficult to Remove (1528); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/11/2017

Event Type  malfunction  

Event Description

Upon first ibi catheter inserted, dr.Tried to cannulate coronary sinus (cs).Pulled catheter back and noticed catheter was bent in half between electrodes 8 and 9.The catheter removed from body.New ibi catheter inserted.Cs cannulated without issue, the doctor proceeded with case.At end of case, staff was pulling out catheters and encountered resistance with the ibi catheter.The dr.Then proceeded to manipulate catheter.Upon fluoroscopy catheter was noted to be bent.Vascular consult was called.The dr.Proceeded to remove the other 2 sheaths from the groin and pull back the 3rd sheath that had the ibi catheter inside it.After all 3 sheaths were out of the groin, the dr.Proceeded to pull out the ibi catheter.Manual pressure held on groin.A second ibi catheter is noted to have the bend between electrode 6 and 7.At this time no harm to patient.Vascular consult cancelled per the dr.

• Brand Name: INQUIRY¿
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): IRVINE BIOMEDICAL, INC.; 2375 morse ave.; irvine CA 92614
• MDR Report Key: 6442290
• MDR Text Key: 71137414
• Report Number: 6442290
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Unknown
• Device Model Number: IBI-81531
• Device Catalogue Number: IBI-81531
• Device Lot Number: 5690765
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/09/2017
• Event Location: Hospital
• Date Report to Manufacturer: 03/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 62 YR