MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM ASPIRATION CATHETER 6; DXE

Model Number CAT6

Device Problems Stretched (1601); Material Twisted/Bent (2981)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/29/2020

Event Type  malfunction  

Event Description

The patient was undergoing a thrombectomy procedure in the superior mesenteric artery (sma) using an indigo system aspiration catheter 6 (cat6) and neuron max 6f 088 long sheath (neuron max).During the procedure, the physician removed thrombus proximally in the sma using the neuron max.The physician then noticed a bifurcation of the sma that became thrombosed.Subsequently, while inserting the cat6 using the peel away sheath, it was noticed under fluoroscopy that the cat6 became bent between the mid shaft and towards the distal end.Therefore, the cat6 was removed and upon further inspection, the physician confirmed the cat6 was stretched.The procedure was completed by administering tissue plasminogen activator (tpa).There was no report of an adverse effect to the patient.

Manufacturer Narrative

The product was not returned for evaluation.Without the return of the device, an investigation cannot be performed.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• Brand Name: INDIGO SYSTEM ASPIRATION CATHETER 6
• Type of Device: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 11219350
• MDR Text Key: 228406037
• Report Number: 3005168196-2021-00153
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00814548016245
• UDI-Public: 00814548016245
• Combination Product (y/n): Y
• Reporter Country Code: IN
• PMA/PMN Number: K160533
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,12/30/2020

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: 06/20/2021
• Device Model Number: CAT6
• Device Catalogue Number: CAT6
• Device Lot Number: F84232
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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: 12/30/2020
• Initial Date FDA Received: 01/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 35 YR