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

Catalog Number	4002C0925
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2019-01190.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the pericallosal artery using penumbra coil 400s (pc400s) and a penumbra coil 400 detachment handle (handle).During the procedure, the physician positioned the pc400 in the target location and attempted to detach it using the handle, but reported that the pc400 would not detach after several attempts.The pc400 and the handle were therefore removed and were no longer used in the procedure.The procedure was completed using other coils and another handle.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pusher assembly was fractured approximately 5 cm from the proximal end.The proximal fractured segment of the pusher assembly was not returned for evaluation.The pusher assembly was also fractured approximately 88.0 cm from the proximal end.The embolization coil was intact with the pusher assembly distal detachment tip (ddt).The pull wire was present within the ddt.Offset coil winds were present throughout the embolization coil.The proximal end of pusher assembly was removed, and it was noticed the pull wire was fractured.The total length of the pull wire was approximately 168.5 cm.Conclusions: evaluation of the returned pc400 revealed a fractured pusher assembly and pull wire.If the pc400 is forcefully mishandled, damage such as a kink may occur.If the kinked device is further manipulated, the kink may worsen to a fracture.In addition, the pull wire likely fractured simultaneously to the pusher assembly fracture.If the pusher assembly and pull wire is fractured, the pull wire will likely not retract when an attempt to detach the embolization coil is made using the handle.Further evaluation revealed offset coil winds along the embolization coil and an additional pusher assembly fracture.These damages were likely incidental to the reported complaint and may have occurred during packaging for return to penumbra.Evaluation of the returned handle revealed a functional device.During functional testing, the handle was tested using a handle test fixture and performed within specification.The handle body was opened, and a piece of pet was found within the handle body.This likely indicates that the handle was used successfully to separate the pc400¿s pet lock.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: 3005168196-2019-01190.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8709522
• Report Number: 3005168196-2019-01189
• Device Sequence Number: 11315585
• Product Code: HCG
• UDI-Device Identifier: 00814548010571
• UDI-Public: 00814548010571
• Combination Product (Y/N): Y
• Initial Reporter Country: CO
• 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): 05/21/2019
• 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: 08/09/2022
• Device Catalogue Number: 4002C0925
• Device Lot Number: A60416
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/21/2019
• Supplement Date Received by Manufacturer: 08/05/2019
• Initial Report FDA Received Date: 06/18/2019
• Supplement Report FDA Received Date: 08/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 88 YR
• Date Report Sent to FDA: 01/01/2005