MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA COIL 400; HCG, KRD

Catalog Number	4006C0408
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance (2578); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was disposed of by the hospital and is no longer available for return.Without the return of the device, the root cause of the problem cannot be determined.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: 3005168196-2018-00354, 3005168196-2018-00355.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the inferior mesenteric artery (ima) using pod4's, penumbra coil 400's (pc400's) and a lantern delivery microcatheter (lantern).During the procedure, the physician advanced an initial pod4 through the lantern and attempted to deploy the coil in the target vessel; however, the pod4 was not coiling properly and was removed.While attempting to advance a new pc400 into the same lantern, the physician encountered resistance near the hub of the lantern and decided to remove the pc400.The pc400 was then visually inspected in a tray filled with saline and another attempt was made to advance the coil out of its introducer sheath and into the lantern; however, resistance was still encountered so the pc400 was removed.Next, the physician advanced the initial pod4 through the lantern and into the target vessel but the coil did not coil properly and was removed.In the end, the ima was not embolized with coils and stent grafting was performed.It was reported that the lantern, pod4 and pc400 were slightly damaged but the specific details are unknown.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7272262
• Report Number: 3005168196-2018-00353
• Device Sequence Number: 1484061
• Product Code: HCG
• UDI-Device Identifier: 00814548011905
• UDI-Public: 00814548011905
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/16/2018

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: Physician
• Device Expiration Date: 04/24/2025
• Device Catalogue Number: 4006C0408
• Device Lot Number: F75880
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2018
• Initial Report FDA Received Date: 02/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 89 YR