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

Model Number	CAT7DKIT-A
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2021
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.
Event or Problem Description
The patient was undergoing a thrombectomy procedure to treat a venous fistula using an indigo system aspiration catheter 7 (cat7) and a non-penumbra guide sheath.It was noted that the patient¿s anatomy was tortuous.During the procedure, the physician made three passes using the cat7.Next, the physician removed the cat7 to be flushed; however, while retracting, resistance was encountered and the mid-shaft of the cat7 was found to be broken upon removal.Therefore, the cat7 was not used.The procedure was completed using a new cat7 and the same sheath.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned cat7 revealed that the catheter was fractured, and the complaint was confirmed.The probable cause of the failure was due to retracting against resistance during use.If the cat7 is forcefully advanced against resistance, damage such as a kink may occur.Subsequently retracting the kinked cat7 against resistance may result in a fracture.Further evaluation revealed that the cat7 was kinked and ovalized.This damage was incidental to the reported complaint and the root cause could not be determined.Penumbra products 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 7
• Common Device Name: QEW
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 12566313
• Report Number: 3005168196-2021-02186
• Device Sequence Number: 16497758
• Product Code: QEW
• UDI-Device Identifier: 00815948023970
• UDI-Public: 00815948023970
• Combination Product (Y/N): Y
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: K193595
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2021
• 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: 03/14/2024
• Device Model Number: CAT7DKIT-A
• Device Catalogue Number: CAT7DKIT
• Device Lot Number: F104558
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 09/06/2021
• Supplement Date Received by Manufacturer: 10/11/2021
• Initial Report FDA Received Date: 10/02/2021
• Supplement Report FDA Received Date: 10/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Date Report Sent to FDA: 01/01/2005