MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM ASPIRATION CATHETER 8; DXE

Model Number	CAT8STR85
Medical Device Problem Codes	Break (1069); Unraveled Material (1664)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 superficial femoral artery (sfa) and popliteal artery using an indigo system aspiration catheter 8 (cat8).It was noted that a stent that was previously placed in the patient became occluded with thrombus.During the procedure, the physician completed two passes using the cat8.However, the previously placed stent had collapsed slightly when aspiration was turned on.Subsequently, while turning the cat8 in the vessel, the physician noticed the tip of the cat8 became caught at the proximal end of the stent.Consequently, the distal radio-opaque marker band of the cat8 became unraveled and broke off within the patient.The cat8 was then removed and the physician decided to place another stent inside of the previously placed stent.It was also reported that by placing the additional stent, it trapped and secured the broken marker band of the cat8 in place.The procedure was completed using an indigo system aspiration catheter 6 (cat6).There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned cat8 confirmed that the marker band was detached from the device.Further evaluation of the device revealed that the distal tip was damaged.Based on the reported complaint, this damage was likely a result of manipulation the device while the tip of the device was caught at the proximal end of the stent.This distal tip damage likely contributed to the marker band detaching from the device during the procedure.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.H3 other text: placeholder.

• Brand Name: INDIGO SYSTEM ASPIRATION CATHETER 8
• Common Device Name: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10988714
• Report Number: 3005168196-2020-02242
• Device Sequence Number: 777693
• Product Code: DXE
• UDI-Device Identifier: 00814548016269
• UDI-Public: 00814548016269
• Combination Product (Y/N): Y
• Initial Reporter Country: AS
• PMA/510(K) Number: K160533
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2020
• 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: 03/25/2023
• Device Model Number: CAT8STR85
• Device Catalogue Number: CAT8STR85
• Device Lot Number: H10384
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 11/12/2020
• Supplement Date Received by Manufacturer: 01/20/2021
• Initial Report FDA Received Date: 12/10/2020
• Supplement Report FDA Received Date: 02/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR
• Date Report Sent to FDA: 01/01/2005