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

Catalog Number	DH1
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report numbers: 3005168196-2019-01565; 3005168196-2019-01566.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the internal iliac artery (iia) using penumbra coil 400s (pc400s) and a penumbra coil detachment handles (handles).During the procedure, the physician deployed and detached a pc400 into the target vessel using a lantern delivery microcatheter (lantern) and the handle.It was reported that the handle was depressed several times before the first pc400 detached into the vessel.The physician then advanced a second pc400 into the target vessel and attempted to detach it using the same handle; however, the pc400 failed to detach.The procedure was completed using a new handle, the same pc400 and additional pc400s.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the handle was undamaged.The nose cone was removed from the handle body and the handle body was opened.What looks like a pull tube from a pusher assembly was stuck within the handle.The pull tube as removed from the handle body.A 0.020¿ pin gauge was able to be advanced through the nose cone without an issue.Conclusions: evaluation of the returned handle revealed a damaged nose cone and a pull tube was stuck within the handle device housing.If a pc400 is forcefully advanced into the handle, damage such as these may occur.During functional testing, the pull tube was removed from the handle.The handle was then tested using a handle test fixture and actuated the hypotube as well as the pull tube.Subsequently, the nose cone was measured using a pin gauge and was found to be out of specification.This damage likely contributed to the reported inability to detach the coil during the procedure.Penumbra handles are 100% visually inspected and functionally tested during incoming quality 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 numbers: 3005168196-2019-01565 and 3005168196-2019-01566.

• Brand Name: PENUMBRA COIL 400 DETACHMENT HANDLE
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8895042
• Report Number: 3005168196-2019-01564
• Device Sequence Number: 13524641
• Product Code: HCG
• UDI-Device Identifier: 00814548011974
• UDI-Public: 00814548011974
• Combination Product (Y/N): Y
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2019
• 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: 03/29/2021
• Device Catalogue Number: DH1
• Device Lot Number: F82590
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/16/2019
• Supplement Date Received by Manufacturer: 09/06/2019
• Initial Report FDA Received Date: 08/14/2019
• Supplement Report FDA Received Date: 09/11/2019
• 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