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

Catalog Number	4002C0312
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	05/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was kinked approximately 1.5 cm from the proximal end.The embolization coil was intact with its pusher assembly.The introducer sheath was kinked approximately 2.5 cm from the distal tip.Conclusions: evaluation of the pc400 revealed that the introducer sheath was kinked.If device is forcefully handled during insertion, damage such as a kinked introducer sheath may occur.The kink in the introducer sheath likely contributed to the resistance experienced and prevented the coil from being advanced through the introducer sheath during the procedure and functional testing.Further evaluation of the returned device revealed that the pusher assembly was kinked.This kink was likely incidental to the reported failure and may have occurred during packaging for return to penumbra.Evaluation of the returned lantern revealed no visible damage and the device was functional.A demonstration coil was advanced through the microcatheter and out of the distal tip without an issue.Penumbra coils and catheters 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.
Event or Problem Description
The patient was undergoing a coil embolization procedure using penumbra coil 400s (pc400s).During the procedure, the physician felt resistance and was unable to advance a pc400 out of the tip of the introducer sheath and into the hub of a lantern delivery microcatheter (lantern), despite attempting multiple times.The physician removed the pc400 and attempted to advance it out of the introducer sheath on the back table, however was unable to despite attempting multiple times and flushing the pc400.The procedure was therefore completed using a new pc400 and the same lantern.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: 7631738
• Report Number: 3005168196-2018-01238
• Device Sequence Number: 1898689
• Product Code: HCG
• UDI-Device Identifier: 00814548013367
• UDI-Public: 00814548013367
• 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
• Report Date (Section B): 05/24/2018

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: 11/01/2023
• Device Catalogue Number: 4002C0312
• Device Lot Number: F66290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2018
• Initial Report FDA Received Date: 06/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1