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

Catalog Number	4004J25
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	01/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the penumbra coil 400 (pc400) was received folded within its packaging.The pc400 pusher assembly had multiple kinks along its length.The introducer sheath is ovalized approximately 77.0 cm from its proximal end.The embolization coil had several offset coil winds along its length.The outer diameter (od) of the embolization coil was measured and found to be within specification.Conclusions: evaluation of the device revealed the introducer sheath was ovalized in its distal region.This damage may have occurred as a result of mishandling upon inserting the introducer sheath into the rhv.The location of damage on the introducer sheath suggests the possibility that overtightening of the rhv may also have caused this damage.This ovalization likely contributed to the difficulty advancing experienced by the physician.In addition, the offset coil winds likely occurred from forcefully advancing the embolization coil through the damaged introducer sheath.Further evaluation revealed the pusher assembly was kinked in multiple locations along its length.This damage is likely incidental and may have occurred during packaging for return to penumbra facilities.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 coils 400 (pc400¿s).During the procedure, while attempting to advance a pc400 as the third coil into a px slim delivery microcatheter(px slim), the physician experienced resistance and the pc400 would not advance into the px slim.Therefore, the pc400 was removed from the rotating hemostasis valve (rhv) and the introducer sheath was inspected.The physician observed no abnormality and re-attempted to advance the pc400 into the px slim; however, the pc400 would not advance into the px slim and therefore, it was removed.The procedure was completed using a new pc400 and the same px slim.It should be noted that the physician used an rhv and maintained continuous flush.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: 6306072
• Report Number: 3005168196-2017-00153
• Device Sequence Number: 565337
• Product Code: HCG
• UDI-Device Identifier: 00814548011721
• UDI-Public: 00814548011721
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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
• Report Date (Section B): 01/08/2017

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: 03/02/2022
• Device Catalogue Number: 4004J25
• Device Lot Number: A41827
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2017
• Initial Report FDA Received Date: 02/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1