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

Catalog Number	CAT3
Medical Device Problem Codes	Unraveled Material (1664); Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the cat3 was fractured approximately 101.7 cm from the hub.The cat3 was damaged and, therefore, could not be functionally tested.Conclusions: evaluation of the returned cat3 revealed that the catheter was fractured.If the device is forcefully retracted out of its packaging hoop at an extreme angle, damage such as a fracture may occur.Penumbra catheters are visually 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.
Event or Problem Description
During preparation for a thrombectomy procedure, the hospital staff found that the indigo system cat3 aspiration catheter (cat3) was unraveling upon removal from the packaging.The damage to the cat3 was found prior to use.Therefore, the cat3 was not used in the procedure.The procedure was completed using a new cat3.

• 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: 7847355
• Report Number: 3005168196-2018-01719
• Device Sequence Number: 1338152
• Product Code: DXE
• UDI-Device Identifier: 00814548016085
• UDI-Public: 00814548016085
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K160533
• 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
• Report Date (Section B): 08/06/2018
• 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 Expiration Date: 09/14/2020
• Device Catalogue Number: CAT3
• Device Lot Number: F79544
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2018
• Initial Report FDA Received Date: 09/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005