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

Catalog Number	CAT8XTORQ115
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/09/2019
Type of Reportable Event	Malfunction
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 popliteal artery and femoral vein using an indigo system aspiration catheter 8 (cat8).It should be noted that the patient's anatomy was very tortuous with many collaterals.During the procedure, the physician positioned the non-penumbra sheath in the target vessel and introduced the cat8.However, the physician encountered resistance and the cat8 became stuck in the sheath.While attempting to retract the cat8 from the sheath, the physician encountered resistance before inadvertently removing the cat8 and sheath together from the patient.The physician then made the decision to end the procedure and continue at a later date with a different approach.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the cat8 was kinked approximately 51.5 and 59.5 cm from the hub.The device was stretched starting from approximately 59.5 cm from the hub.The cat8 was fractured approximately 66.5 cm from the hub and the coil winds within the cat8 was stretched.The distal fractured portion was stuck within the non-penumbra sheath.Conclusions: evaluation of the returned cat8 confirmed the cat8 was stuck within the non-penumbra sheath.During functional testing, resistance was experienced while attempting to advance a demonstration cat8 through the non-penumbra sheath and became stuck in a similar location as the returned cat8.This indicates the non-penumbra sheath was likely the root cause of the resistance experienced during the procedure.Further evaluation revealed kinks and fractures on the returned cat8 that were likely a result of the device becoming stuck within the non-penumbra sheath.Additional damage was caused during removal of the returned cat8 from the non-penumbra sheath.Penumbra catheters are inspected during in-process inspection and during quality inspection after manufacturing.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.

• 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: 9163543
• Report Number: 3005168196-2019-01872
• Device Sequence Number: 1912664
• Product Code: DXE
• UDI-Device Identifier: 00814548016290
• UDI-Public: 00814548016290
• Combination Product (Y/N): Y
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K142870
• 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): 09/09/2019
• 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 Catalogue Number: CAT8XTORQ115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 09/09/2019
• Supplement Date Received by Manufacturer: 11/14/2019
• Initial Report FDA Received Date: 10/07/2019
• Supplement Report FDA Received Date: 11/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 84 YR
• Date Report Sent to FDA: 01/01/2005