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

Catalog Number	4004C0820
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/30/2017
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the coronary artery using penumbra coil 400''s (pc400''s).During the procedure, the physician advanced a pc400 approximately forty to fifty centimeters through the introducer sheath and towards the px slim delivery microcatheter (px slim) but then encountered resistance and was unable to advance the coil further.Therefore, the pc400 was resheathed back into its introducer sheath and the physician confirmed that the coil could be advanced and retracted through its introducer sheath.Thereafter, the px slim was flushed with a syringe and another attempt was made to advance the same pc400.However, the physician encountered resistance and was unable to advance the pc400 at the same location.Therefore, the pc400 was removed and the procedure was completed using a new pc400 and the same px slim.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the penumbra coil 400 (pc400) pusher assembly was bent in multiple locations.The embolization coil had multiple offset coil winds approximately 4.5 cm from the proximal constraint sphere.Conclusions: evaluation of the returned device revealed that the pc400 embolization coil had offset coil winds.During functional analysis, it was observed that the offset coil winds contributed to resistance when the embolization coil was being advanced out of the introducer sheath.Offset coil winds typically occurs if the embolization coil is manipulated forcefully against resistance.The root cause of the initial resistance experienced during the procedure could not be determined.Further evaluation revealed that the pusher assembly was bent in multiple locations.This damage was likely incidental and may have occurred due to improper handling during packaging of the device for return.The px slim mentioned in the complaint was not returned for evaluation.Penumbra coils and catheters 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.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6366806
• Report Number: 3005168196-2017-00257
• Device Sequence Number: 16155075
• Product Code: HCG
• UDI-Device Identifier: 00814548010922
• UDI-Public: 00814548010922
• Combination Product (Y/N): N
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2017

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: 09/07/2023
• Device Catalogue Number: 4004C0820
• Device Lot Number: F65608
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/30/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/28/2017
• Supplement Report FDA Received Date: 05/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1