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	11/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional 510(k) that also applies to this complaint: k193595.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 to treat a fistula using an indigo system aspiration catheter 7d (cat7d) and a non-penumbra sheath.During the procedure, the physician completed a few passes using the cat7d.Next, the physician over torqued the cat7d and subsequently noticed under fluoroscopy that the cat7d fractured at the mid-shaft in the patient's arm.The physician then removed the fractured part of the cat7d using a snare device and additionally performed a cut down to accommodate the catheter coming out of the vessel and inserted a new sheath to complete the procedure.The procedure was completed using an indigo system aspiration catheter 8 (cat8).There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned cat7d confirmed a fracture.Evaluation revealed signs of kinking and torquing at the fracture site.Based on the reported event, the cat7d was torqued unrestrained against resistance after a few successful passes during the procedure.If the cat7d is torqued unrestrained against resistance, damage such as a fracture may occur.Further evaluation revealed a kink on the midshaft and multiple ovalizations along the length.This damage was incidental to the complaint and likely occurred during removal of the device.Some of this damage may have occurred during packaging for return to penumbra.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 (Section G): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 20894163
• Report Number: 3005168196-2024-00409
• Device Sequence Number: 21025969
• Product Code: QEW
• UDI-Device Identifier: 00815948023970
• UDI-Public: 00815948023970
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K210083
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2024

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 Catalogue Number: CAT7DKIT
• Device Lot Number: H00004319
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2024
• Supplement Date Received by Manufacturer: 12/06/2024
• Initial Report FDA Received Date: 12/10/2024
• Supplement Report FDA Received Date: 12/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/02/2024
• 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: 64 YR
• Patient Sex: Male