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

Model Number	4004C0815
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/21/2019
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure using penumbra coil 400s (pc400s) and a non-penumbra microcatheter.During the procedure, the pc400 prematurely detached.No additional information regarding the completion of the procedure has been provided.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of its pusher assembly.The stretch resistance wire (sr wire) was fractured and the embolization coil was detached from its pusher assembly.Offset coil winds were present throughout the embolization coil.Conclusions: evaluation of the returned pc400 revealed that the sr wire was fractured.This type of damage typically occurs if the pc400 is forcefully retracted against resistance.If the sr wire fractures, the embolization coil will detach from its pusher assembly.No other devices associated with the complaint were returned for evaluation; therefore, the root cause of resistance could not be determined.Penumbra coils are visually inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9825970
• Report Number: 3005168196-2020-00341
• Device Sequence Number: 11104383
• Product Code: HCG
• UDI-Device Identifier: 00814548011707
• UDI-Public: 00814548011707
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2020
• 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: 08/25/2022
• Device Model Number: 4004C0815
• Device Catalogue Number: 4004C0815
• Device Lot Number: F60552
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/20/2020
• Supplement Date Received by Manufacturer: 03/27/2020
• Initial Report FDA Received Date: 03/12/2020
• Supplement Report FDA Received Date: 04/20/2020
• 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