MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM CAT 5 ASPIRATION CATHETER; DXE

Catalog Number	CAT5
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/19/2017
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.This report is associated with mfr report number: 3005168196-2017-02179.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the mesenterial artery using an indigo system cat5 aspiration catheter and an indigo system cat3 aspiration catheter.During the procedure, while advancing the cat5 through a non-penumbra sheath, the cat5 became stuck after being advanced approximately 8-10 centimeters into the sheath; therefore, it was removed.The physician then advanced a cat3 through a non-penumbra sheath to the target location and began aspiration.However, while retracting the cat3 to remove the clot, the physician experienced resistance and the cat3 broke into two parts approximately 15 centimeters from the distal tip.The broken cat3 was completely removed from the patient since the broken parts were still contained within the sheath.The clot was not removed and the procedure stopped at that point.There was no report of an adverse effect to the patient.Afterwards the patient successfully underwent vascular surgery to remove the clot.
Additional Manufacturer Narrative
Results: there was no visible damage to the cat5.Conclusions: evaluation of the returned cat3 revealed a fractured along the catheter's length.This damage is likely a result of retracting the device against resistance.Further evaluation revealed the device was ovalized on its distal shaft.This damage may have been due to improper handing during preparation or forcefully advancing the device against resistance.The non-penumbra sheath mentioned in the complaint was not returned for evaluation and, therefore, the root cause of the resistance could not be determined.Evaluation of the returned cat5 revealed on visible damage to the device.It was measured to be within specification.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.This report is associated with mfr report number: 3005168196-2017-02179.

• Brand Name: INDIGO SYSTEM CAT 5 ASPIRATION CATHETER
• Common Device Name: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7104428
• Report Number: 3005168196-2017-02178
• Device Sequence Number: 685755
• Product Code: DXE
• UDI-Device Identifier: 00814548016092
• UDI-Public: 00814548016092
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 11/13/2017

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: Physician
• Device Expiration Date: 01/04/2020
• Device Catalogue Number: CAT5
• Device Lot Number: F73488
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/13/2017
• Supplement Date Received by Manufacturer: 01/11/2018
• Initial Report FDA Received Date: 12/11/2017
• Supplement Report FDA Received Date: 02/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR