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

Catalog Number	CAT8STR85
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/08/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: both indigo system aspiration catheter 8 (cat8) devices were kinked throughout their lengths.Both cat8 devices were ovalized on the distal tip.Conclusions: evaluation of the returned devices confirmed that the distal tips of the cat8 devices were ovalized.This type of damage typically occurs due to improper handling during use.If the cat8 distal tip is forcefully gripped during insertion into the patient, this type of damage may occur.The evaluation also revealed multiple kinks along the catheter shafts.This damage was likely incidental, and likely occurred due to improper handling during packaging for return.Penumbra catheters are 100% visually evaluated during in-process inspection.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: 3005168196-2016-00131.
Event or Problem Description
The patient was undergoing a thrombectomy procedure for a deep vein thrombosis (dvt) using indigo system aspiration catheter 8 (cat8) devices.During the procedure, while two cat8 devices were being advanced back to back through another manufacturer's sheath, they both became ovalized at the distal tip and were both removed from the patient.The procedure was completed using a new cat8.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: 5403146
• Report Number: 3005168196-2016-00132
• Device Sequence Number: 589169
• Product Code: DXE
• UDI-Device Identifier: 00814548016269
• UDI-Public: 00814548016269
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K142870
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Report Date (Section B): 01/08/2016

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: 07/22/2018
• Device Catalogue Number: CAT8STR85
• Device Lot Number: F64994
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2016
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/01/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1