MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM CAT3 ASPIRATION CATHETER; DXE

Catalog Number	CAT3
Medical Device Problem Code	Kinked (1339)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/06/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.The hospital disposed of the device.
Event or Problem Description
The patient was undergoing a thrombectomy procedure using an indigo system cat3 aspiration catheter (cat3).During the procedure, the physician successfully used an indigo system aspiration catheter 6 (cat6) to remove clot and decided to use the cat3 to remove a distal clot.However, the physician was unable to establish blood flow and upon removal of the cat3 from the patient, a kink was observed.The physician decided to treat the patient with tissue plasminogen activator (tpa) for another night and then retreat the patient the next day using an indigo system aspiration catheter 5 (cat5).The cat5 performed as intended and the physician was able to remove clot in the tibial artery; however, the patient continued to clot because his anticoagulation medications were not effective.Following the procedure, the patient was going to see a vascular surgeon.There was no report of an adverse effect to the patient.

• Brand Name: INDIGO SYSTEM CAT3 ASPIRATION CATHETER
• Common Device Name: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5481616
• Report Number: 3005168196-2016-00281
• Device Sequence Number: 445750
• Product Code: DXE
• UDI-Device Identifier: 00814548013299
• UDI-Public: 00814548013299
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K121917
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/06/2016

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: 05/18/2018
• Device Catalogue Number: CAT3
• Device Lot Number: F64014
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2016
• Initial Report FDA Received Date: 03/04/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR