MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM; CATHETER, EMBOLECTOMY

Model Number CATRXKIT

Device Problem Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/14/2020

Event Type  malfunction  

Event Description

During left heart catheterization and lv angiography/selective coronary angiography of right and left coronary arteries, ultrasound guided right cfa (common femoral artery)arteriotomy, md attempted to use penumbra cat rx catheter for an arthrectomy procedure.He proceeded to insert the 6f penumbra cat rx catheter through the ebu 3.5 guiding cath but it would not go up in the groin.At the time, md had 2 runthrough wires in, so he removed one.He then tried the penumbra cath again but still did not go up the groin.He removed the penumbra again, wiped down and flushed.It still had same issue.Device taken off field and another device of same kind was used.There was groin access with a 6 f merit sheath in the right femoral artery.An ebu 3.5 medtronic guiding catheter was attached to a co-pilot.The runthrough wire was being fed through the small side hole.The wire would exit and the scrub tech would pin it in place.With all that done, the penumbra still could not be advanced up to the heart, so therefore it could not be sutured as intended.Procedure was successful with use of same type of device, but different brand.No harm to patient.

• Brand Name: INDIGO SYSTEM
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): PENUMBRA, INC.; 6262 patterson pass rd, suite a; livermore CA 94550
• MDR Report Key: 10183533
• MDR Text Key: 196068578
• Report Number: 10183533
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2020
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: CATRXKIT
• Device Catalogue Number: CATRXKIT
• Device Lot Number: F94677
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/18/2020
• Event Location: Hospital
• Date Report to Manufacturer: 06/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 16790 DA