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

Catalog Number	4002C1335
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the penumbra coil 400 (pc400) pusher assembly was kinked approximately 5.0 cm from its proximal end and bent approximately 15.0 cm from its hub.The embolization coil was compressed and had several offset coil winds along its length.Coagulated blood was observed inside the introducer sheath and on the embolization coil.During functional analysis, the pc400 was partially advanced through a demonstration px slim.When attempting to retract the coil it would not fully resheath inside its introducer sheath.Conclusions: evaluation of the returned pc400 revealed that the embolization coil was compressed and had offset coil winds along its length.This damage is likely a result of forcefully advancing the embolization coil against resistance.The root cause of this resistance could not be determined.However, the coagulated blood present inside introducer sheath and on the coil may have contributed to any resistance experienced by the physician.Further evaluation revealed that the pusher assembly was kinked and bent.These damages are likely a result of continued attempts to advance the embolization coil against resistance.The px slim mentioned in the complaint was not returned for evaluation.Penumbra coils are 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.
Event or Problem Description
The patient was undergoing a coil embolization procedure using penumbra coil 400s (pc400s).During the procedure, the physician attempted to advance an initial pc400 out of its introducer sheath and into the px slim delivery microcatheter (px slim) but the coil would not advance out.Therefore, the introducer sheath containing the pc400 was removed and the procedure was completed using nine new pc400s and 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: 6693175
• Report Number: 3005168196-2017-01113
• Device Sequence Number: 831788
• Product Code: HCG
• UDI-Device Identifier: 00814548010656
• UDI-Public: 00814548010656
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 06/08/2017

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: 06/30/2023
• Device Catalogue Number: 4002C1335
• Device Lot Number: F64346
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2017
• Initial Report FDA Received Date: 07/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR