MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM ASPIRATION CATHETER 3; DXE

Catalog Number	CAT3
Medical Device Problem Codes	Break (1069); Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/01/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the indigo system aspiration catheter 3 (cat3) was fractured approximately 105.0 cm from the hub; the cat3 distal shaft was ovalized approximately 3.5, 4.5, and 14.0 thru 19.5 cm from the distal tip.Conclusions: evaluation of the returned device revealed that the cat3 was fractured and ovalized.These types of damage typically occur due to improper handling during preparation.If the device is removed from the packaging hoop at an angle while applying force, damage such as a fracture and ovalization may occur.Cat3s are 100% visually inspected during in-process inspection.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
Event or Problem Description
During preparation for a thrombectomy procedure, the hospital staff noticed the indigo system aspiration catheter 3 (cat3) was broken.The broken cat3 was found prior to use; therefore, it was not used during the procedure.The procedure was completed using a penumbra system 3max reperfusion catheter.

• Brand Name: INDIGO SYSTEM ASPIRATION CATHETER 3
• Common Device Name: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5618159
• Report Number: 3005168196-2016-00586
• Device Sequence Number: 356606
• Product Code: DXE
• UDI-Device Identifier: 00814548013299
• UDI-Public: 00814548013299
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 04/01/2016

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: 07/31/2017
• Device Catalogue Number: CAT3
• Device Lot Number: F45188
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2016
• Initial Report FDA Received Date: 04/28/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Weight: 99