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

Catalog Number	CAT7DKIT
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the cephalic vein an indigo system aspiration catheter 7d (cat7 d), an 8f non-penumbra sheath, and a guidewire.During the procedure, the physician inserted the cat7 d with the guidewire into the sheath using the introducer.Next, the introducer was pushed to the proximal end of the cat7 d, the guidewire was then removed, and the physician-initiated aspiration.After advancing and retracing multiple times with the cat7 d in the vessel, the physician decided to remove the cat7 d to be flushed.However, while retracting, the physician kinked the cat7 d approximately 10 centimeters from the distal end and consequently, the cat7 d broke at the kinked location.Therefore, the cat7 d was removed and was not used for the remainder of the procedure.The procedure was completed using a new cat7 d with the same introducer and same sheath.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Additional 510(k)# that also apply to this complaint: k210083 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 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: 15156805
• Report Number: 3005168196-2022-00367
• Device Sequence Number: 5235036
• Product Code: QEW
• UDI-Device Identifier: 00815948023970
• UDI-Public: 815948023970
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/03/2022
• 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: 03/29/2025
• Device Catalogue Number: CAT7DKIT
• Device Lot Number: H12833
• Was Device Available for Evaluation?: No
• 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: 07/07/2022
• Initial Report FDA Received Date: 08/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2022
• 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
• Patient Age: 50 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005