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

Model Number CAT6

Device Problems Material Deformation (2976); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/16/2021

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2021-01785, 3005168196-2021-01786.

Event Description

The patient was undergoing a thrombectomy procedure in the peroneal and posterior tibial using an indigo system aspiration catheter 6 (cat6) and a non-penumbra sheath.During the procedure, while inserting a cat6 using a peel-away sheath into the sheath, the physician experienced resistance.Subsequently, the physician stretched and ovalized the distal tip of the cat6; therefore, the cat6 was removed.The physician then completed one pass using a new cat6 that removed some clot.Afterwards, while re-inserting the cat6 through the peel-away sheath, the physician experienced resistance at the distal tip of the cat6.Subsequently, the physician kinked the cat6; therefore, the cat6 was removed.Then, while attempting to advance a penumbra system ace 68 reperfusion catheter (ace68) through the sheath, the physician experienced resistance.Subsequently, the physician ovalized the distal end of the ace68.Therefore, the ace68 and sheath were removed.The procedure was completed using a new cat6 and a new non-penumbra sheath.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Correction: please note that the following sections were incorrectly reported on the initial mfr report and are being corrected on this follow-up: 1.Section d.Box 10.Device available for evaluation? additional information: please note that the following sections are being updated based on additional information provided by a penumbra sales representative on 10/01/2021: 1.Section h.Box 3.Reason for non-evaluation.1.Section h.Box 3.''other'' reason for non-evaluation.1.Section h.Box 6.Method code 1.1.Section h.Box 6.Method code 2.1.Section h.Box 6.Method code 3.1.Section h.Box 6.Results code 1.1.Section h.Box 6.Conclusions code 1.The product was not returned for evaluation.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 ASPIRATION CATHETER 6
• Type of Device: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 12307585
• MDR Text Key: 266033343
• Report Number: 3005168196-2021-01784
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00814548016245
• UDI-Public: 00814548016245
• Combination Product (y/n): Y
• PMA/PMN Number: K160533
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,10/06/2021

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: 08/26/2023
• Device Model Number: CAT6
• Device Catalogue Number: CAT6
• Device Lot Number: F99814
• 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: 07/16/2021
• Initial Date FDA Received: 08/11/2021
• Supplement Dates Manufacturer Received: 10/01/2021
• Supplement Dates FDA Received: 10/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 56 YR