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

Model Number	CAT6
Medical Device Problem Codes	Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2021
Type of Reportable Event	Malfunction
Additional 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: 3005168196-2021-02053.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the vena cava using an indigo system aspiration catheter 6 (cat6) and a non-penumbra diagnostic catheter.During the procedure, the physician experienced resistance using the cat6.It should be noted that the supplied peel away sheath was not used with the cat6.When the cat6 was removed, the distal end of the cat6 was observed to be kinked.Subsequently, the physician used a second cat6.A peel away sheath was not used with this cat6.As the physician turned on aspiration when advancing the cat6, the distal end of the cat6 was noticed under fluoroscopy to have collapsed.It was reported the cat6 was still in the introducer sheath.Therefore, the cat6 was removed.The procedure was completed using an indigo system catrx aspiration catheter (catrx) and a new guide catheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the first returned cat6 revealed an ovalization on the distal shaft.This confirms the reported damage on its distal shaft.It was reported that the peel away sheath, packaged with the cat6, was not utilized during advancement.This is likely the probable cause of the reported damage.If the peel away sheath is not properly utilized to protect the cat6 distal shaft during advancement, damage such as an ovalization may occur.During functional testing, resistance was experienced while attempting to advance the cat6 through a demonstration neuron max due to the ovalization, and the cat6 could not advance any further.Evaluation of the second returned cat6 revealed an ovalization and kinks on the distal shaft.This confirms the reported damage on the distal shaft.It was reported that the peel away sheath, packaged with the cat6, was not utilized during advancement.This is likely the probable cause of the reported damage.If the peel away sheath is not properly utilized to protect the cat6 distal shaft during advancement, damage such as an ovalization may occur.Subsequently, if the device is advanced against resistance, damage such as kinks may occur.During functional testing, resistance was experienced while attempting to advance the cat6 through a demonstration neuron max due to the ovalization, and the cat6 could not advance any further.Penumbra catheters are inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.This report is associated with mfr report number: 1.3005168196-2021-02053.

• Brand Name: INDIGO SYSTEM ASPIRATION CATHETER 6
• Common Device Name: QEW
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 12478197
• Report Number: 3005168196-2021-02052
• Device Sequence Number: 20056730
• Product Code: QEW
• UDI-Device Identifier: 00814548016245
• UDI-Public: 00814548016245
• Combination Product (Y/N): Y
• Initial Reporter Country: CA
• PMA/510(K) Number: K192833
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2021
• Report Date (Section F): 01/01/2005

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/04/2022
• Device Model Number: CAT6
• Device Catalogue Number: CAT6
• Device Lot Number: F92313
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/26/2021
• Supplement Date Received by Manufacturer: 10/01/2021
• Initial Report FDA Received Date: 09/15/2021
• Supplement Report FDA Received Date: 10/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 1 YR
• Patient Weight: 40
• Date Report Sent to FDA: 01/01/2005