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

Catalog Number	4002C1857
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/14/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the embolization coil was detached from the penumbra coil 400 (pc400) pusher assembly with the proximal constraint sphere intact.The embolization coil was damaged throughout its length.The embolization coil and proximal constraint sphere was measured and found to be within specification.Conclusions: evaluation of the first pc400 revealed the embolization coil was damaged throughout its length.This damage likely occurred due to forceful manipulation of the pc400 against resistance.Further evaluation revealed that the embolization coil outer diameter (od), and the od of the embolization coil proximal constraint sphere were within specification.Since the pusher assembly was not returned, the root cause of the difficulty advancing through the px slim delivery microcatheter (px slim), as well as the root cause of the unintentional detachment, could not be determined.Evaluation of the second pc400 revealed the pusher assembly was fractured and kinked.This damage likely occurred due to forceful manipulation of the pc400 at extreme angles.Fracture of the pusher assembly may expose the pull wire, which may allow the embolization coil to detach.The px slim mentioned in the complaint, the first pc400¿s pusher assembly and introducer sheath, and the second pc400¿s embolization coil and introducer sheath were all not returned for evaluation.All penumbra coils are functionally evaluated during in-process 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: 3005168196-2016-00495.
Event or Problem Description
The patient was undergoing a coil embolization procedure for a fistula using penumbra coils 400 (pc400 coils).During the procedure, the physician had difficulty advancing a pc400 coil through a px slim delivery microcatheter (px slim).Upon retracting the pc400 coil pusher assembly, the physician noticed that the pc400 coil had unintentionally detached in the hub of the px slim and it was removed.While advancing a new pc400 coil through the px slim, it unintentionally detached and was pushed in the aneurysm using a guide wire.The procedure was completed using six new pc400 coils with the same px slim.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: 5575386
• Report Number: 3005168196-2016-00494
• Device Sequence Number: 13517391
• Product Code: HCG
• UDI-Device Identifier: 00814548010748
• UDI-Public: 00814548010748
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/18/2016

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: 08/16/2023
• Device Catalogue Number: 4002C1857
• Device Lot Number: F65366
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2016
• Initial Report FDA Received Date: 04/13/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR