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

Catalog Number	4002C1857
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	05/12/2017
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 renal artery using penumbra coil 400's (pc400's).During the procedure, the physician advanced a px slim delivery microcatheter (px slim) into the target vessel, then deployed and detached two pc400's and three non-penumbra coils.While attempting to advance a new pc400 through the px slim, the physician encountered resistance and was unable to advance the coil out of the tip of the px slim.Therefore, the physician retracted the pc400, flushed the px slim and then made another attempt to advance the coil.However, resistance was met again and the pc400 was removed.Thereafter, the procedure was completed using the same px slim and a new pc400.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 the penumbra coil 400 (pc400) pusher assembly.The embolization coil was intact with its pusher assembly.The distal tip of the introducer sheath had dried blood inside.Conclusions: evaluation of the returned device revealed that the pc400 was functional.The distal tip of the introducer sheath had dried blood inside the lumen.The distal tip of the introducer sheath was cut off by the penumbra investigator.Then, the pc400 was advanced through a demonstration px slim and out the distal tip without an issue and, therefore, the root cause of the reported 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: 6638893
• Report Number: 3005168196-2017-00910
• Device Sequence Number: 231614
• Product Code: HCG
• UDI-Device Identifier: 00814548010748
• UDI-Public: 00814548010748
• 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): 05/16/2017

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: 09/19/2024
• Device Catalogue Number: 4002C1857
• Device Lot Number: F71700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2017
• Initial Date Received by Manufacturer: 05/16/2017
• Supplement Date Received by Manufacturer: 06/21/2017
• Initial Report FDA Received Date: 06/13/2017
• Supplement Report FDA Received Date: 07/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1