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

Catalog Number	CAT8TORQ85
Medical Device Problem Codes	Device Damaged Prior to Receipt by User (1570); Device Damaged Prior to Use (2284); Device Packaging Compromised (2916)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Results: both indigo system aspiration catheter 8 (cat8¿s) devices were ovalized approximately 26.0 cm from the hub.Conclusions: evaluation of the returned devices revealed that both cat8 devices were ovalized.This type of damage likely occurred due to improper storage of the devices.The display cardboard boxes and shipping box were not returned for evaluation.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 number: 1.3005168196-2017-00724.
Event or Problem Description
During preparation for a thrombectomy procedure, the hospital staff noticed a crease around the mid/distal shaft of two indigo system aspiration catheter 8 (cat8¿s) devices upon opening the device packaging box.Upon further examination, it was observed that the box of the devices was bent right where the crease in the cat8''s were observed.The damaged cat8 devices were found prior to use and therefore, were not used in the procedure.The procedure was completed using a new cat8.

• 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: 6559006
• Report Number: 3005168196-2017-00723
• Device Sequence Number: 19007854
• Product Code: DXE
• UDI-Device Identifier: 00814548016252
• UDI-Public: 00814548016252
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 04/13/2017

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: Health Professional
• Device Expiration Date: 10/31/2019
• Device Catalogue Number: CAT8TORQ85
• Device Lot Number: F72551
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2017
• Initial Report FDA Received Date: 05/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1