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

Catalog Number	CAT7DKIT
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional 510(k) number that also applies to this complaint: k210083.The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the cephalic vein graft using an indigo system aspiration catheter 7d (cat7d) and a non-penumbra sheath.During the procedure, the physician advanced the cat7d through the sheath and to the face of the clot in the arteriovenous (av) graft.While advancing and retracting the cat7d with aspiration for approximately 90 seconds to remove clot in the vessel, the physician fractured the cat7d at the proximal end that was outside of the sheath¿s valve.It was reported that approximately one inch of the fractured cat7d was outside of the sheath.The physician inserted a guidewire through the fractured cat7d and then intentionally cut the proximal end of the cat7d to advance the guidewire further through the cat7d.Afterwards, the physician was able to pull and remove the fractured cat7d and guidewire together as a unit out from the sheath.The procedure was completed using an indigo system aspiration catheter 7 (cat7), the same sheath, and the same guidewire.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned cat7d confirmed a fracture on the catheter shaft.This damage likely occurred during manipulation of the catheter with aspiration to remove clot in the vessel.If the device is repeatedly manipulated against tough clot during use, the catheter shaft may fatigue and subsequently fracture.Further evaluation revealed an additional fracture and kinks on the cat7d.Based on the reported event, the additional fracture is incidental to the reported complaint and was made in an attempt to remove the fractured distal segment of the catheter from the sheath.The root cause of the kinks could not be determined.Penumbra devices are visually 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.H3 other text : placeholder.

• 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: 17936041
• Report Number: 3005168196-2023-00463
• Device Sequence Number: 12362557
• Product Code: QEW
• UDI-Device Identifier: 00815948023970
• UDI-Public: 815948023970
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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,Followup
• Report Date (Section B): 10/27/2023
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/12/2026
• Device Catalogue Number: CAT7DKIT
• Device Lot Number: H00002356
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2023
• 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: 09/18/2023
• Supplement Date Received by Manufacturer: 10/12/2023
• Initial Report FDA Received Date: 10/13/2023
• Supplement Report FDA Received Date: 10/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2023
• 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: 63 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005