MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM CATRX ASPIRATION CATHETER; QEX

Model Number CATRXKIT

Device Problem Suction Problem (2170)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/18/2019

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.

Event Description

The patient was undergoing a thrombectomy procedure in the right coronary artery (rca) using an indigo system catrx aspiration catheter (catrx) and a penumbra system aspiration pump max 110 (pump max).During the procedure, the physician was unable to aspirate in the target vessel using the catrx and pump max; therefore, the catrx was removed, and the hospital staff troubleshooted the pump max to determine if there were any air leaks.Upon removal, the catheter was observed to have no noticeable damage, and the pressure gauge on the pump max was reading at the standard -28 inhg.It was reported that the hospital staff did not find any issue with the pump max.The procedure was completed using another catrx, the same pump max, and a stent was placed in the vessel.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Please note that the following section was incorrectly reported on the follow-up #01 mfr report:3005168196-2020-00031 and is being corrected on this follow-up #02 mfr report:3005168196-2020-00031.1.Section h.Box 6.Conclusion code 1 h3 other text : placeholder.

Manufacturer Narrative

Please note that the device associated with this complaint was expected to be returned; however, additional information received from the penumbra sales representative indicated that the device is no longer available for return.Therefore, without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• Brand Name: INDIGO SYSTEM CATRX ASPIRATION CATHETER
• Type of Device: QEX
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9572187
• MDR Text Key: 176999590
• Report Number: 3005168196-2020-00031
• Device Sequence Number: 1
• Product Code: QEX
• UDI-Device Identifier: 00814548017556
• UDI-Public: 00814548017556
• Combination Product (y/n): Y
• PMA/PMN Number: K163618
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,12/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/17/2022
• Device Model Number: CATRXKIT
• Device Catalogue Number: CATRXKIT
• Device Lot Number: C18918
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 12/18/2019
• Initial Date FDA Received: 01/09/2020
• Supplement Dates Manufacturer Received: 02/05/2020; 01/14/2005
• Supplement Dates FDA Received: 02/06/2020; 03/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1