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

Catalog Number	CAT8TORQ85
Medical Device Problem Code	Bent (1059)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the cat8 was kinked approximately 34.5, 63.0, and 78.5 cm from the hub.Bends were present along the length of the cat8.Conclusions: evaluation of the returned cat8s revealed kinked devices.This type of damage typically occurs due to improper handling during removal from packaging.If a device is forcefully retracted at extreme angles during removal from the packaging or otherwise mishandled during preparation, damage such as kinks may occur.Further evaluation revealed kinks and bends along the length of the cat8s.Based on the return condition, some of these kinks and bends are likely incidental to the complaint and may have occurred during packaging for return to penumbra.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.This report is associated with mfr report numbers: 3005168196-2018-01255.
Event or Problem Description
The patient was undergoing a thrombectomy procedure using indigo system aspiration catheters 8 (cat8s).During the procedure, the hospital staff noted that two cat8s were bent when they were introduced into the opening of the sheath and therefore, the cat8s were removed.The procedure was completed using a new cat8 and an indigo system catd aspiration catheter (catd).There was no report of an adverse effect to the patient.

• 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: 7635668
• Report Number: 3005168196-2018-01256
• Device Sequence Number: 2376330
• Product Code: DXE
• UDI-Device Identifier: 00814548016252
• UDI-Public: 00814548016252
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 05/27/2018

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: 02/06/2021
• Device Catalogue Number: CAT8TORQ85
• Device Lot Number: F81794
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2018
• Initial Report FDA Received Date: 06/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 118