MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM ASPIRATION CATHETER 7D; QEW

Catalog Number	CAT7DKIT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a thrombectomy procedure using an indigo system aspiration catheter 7 d (cat7 d).During the procedure, while torqueing the cat7 d in the target location to remove clot, the distal end of the cat7 d broke off.It was reported there was chronic clot in the aneurysm.The physician then attempted to use a snare device to remove the broken cat7 d; however, the attempt was unsuccessful.The patient was taken to surgery to remove the remaining broken cat7 d.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Additional 510(k)# that also apply to this complaint: (b)(4).This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Additional Manufacturer Narrative
Please note that the following sections were inadvertently missed on the follow-up #01 mfr report and are being included on this follow-up #02 mfr report: 3005168196-2022-00442.Section d.Box 10.Device available for evaluation?; section d.Box 10.Returned to manufacturer.
Additional Manufacturer Narrative
Please note that this complaint was submitted to the fda by the user facility with the following reference number: mw5112230.Evaluation of the returned cat7d confirmed that the distal end of the catheter was fractured.Based on the damage at the fracture site, the fracture was likely the result of torqueing against resistance.If the device is over torqued against resistance, damage such as a kink and subsequent fracture may occur.Based on the reported event, the root cause of resistance could not be determined.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.

• Brand Name: INDIGO SYSTEM ASPIRATION CATHETER 7D
• Common Device Name: QEW
• 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: 15466120
• Report Number: 3005168196-2022-00442
• Device Sequence Number: 6842488
• Product Code: QEW
• UDI-Device Identifier: 00815948023970
• UDI-Public: 815948023970
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K193595
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/02/2023
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/21/2024
• Device Catalogue Number: CAT7DKIT
• Device Lot Number: F104730
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2022
• Supplement Date Received by Manufacturer: 02/03/2023; 01/14/2005
• Initial Report FDA Received Date: 09/22/2022
• Supplement Report FDA Received Date: 03/02/2023; 03/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/01/2005