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

Catalog Number	4006C0408
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/20/2018
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 number: 3005168196-2019-00180.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the inferior mesenteric artery (ima) using penumbra coil 400s (pc400s) and a penumbra coil 400 detachment handle (handle).During the procedure, the physician advanced a pc400 in the target vessel using a non-penumbra microcatheter and attempted to detach it using a handle; however, the pc400 failed to detach.Therefore, the pc400 and handle were removed.The procedure was completed using additional pc400s and a new handle.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the penumbra coil 400 (pc400) pet lock was intact and undamaged on the proximal end of the pusher assembly.Multiple bends and kinks were present along the length of the pusher assembly.The embolization coil was detached from the distal detachment tip (ddt) of the pusher assembly.The pull wire and proximal constraint sphere were present within the ddt.The stretch resistant (sr) wire within the embolization coil was fractured.Offset coil winds were present along the length of the coil.Conclusions: evaluation of the returned pc400 revealed a device with an intact and undamaged proximal pet lock.If the handle is not properly seated on the pusher assembly prior to actuation the pet lock may not separate.If the pet lock does not separate, the pull wire will not retract from the ddt to detach the embolization coil.Further evaluation of the returned pc400 revealed a fractured sr wire, offset coil winds, and kinks and bends along the length of the device.Based on the reported complaint, these damages were likely incidental to the complaint and may have occurred during packaging for return to penumbra.Evaluation of the returned handle revealed an undamaged device.The handle was tested using a handle test fixture and performed within specification.During functional testing, the returned handle was able to separate the pet lock and successfully detach the returned embolization coil.Penumbra coils are inspected during in-process inspection and during quality inspection after manufacturing.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 number: 3005168196-2019-00180.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8304780
• Report Number: 3005168196-2019-00179
• Device Sequence Number: 13467614
• Product Code: HCG
• UDI-Device Identifier: 00814548011905
• UDI-Public: 00814548011905
• 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): 01/06/2019
• 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: 07/18/2025
• Device Catalogue Number: 4006C0408
• Device Lot Number: F78240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/06/2019
• Supplement Date Received by Manufacturer: 03/12/2019
• Initial Report FDA Received Date: 02/05/2019
• Supplement Report FDA Received Date: 04/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Date Report Sent to FDA: 01/01/2005