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	11/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pc400 introducer sheath was kinked approximately 4.0 cm from its distal end.Conclusions: evaluation of the returned pc400 revealed a kinked introducer sheath.This damage was likely due to improper handling during preparation of the pc400.If this introducer sheath becomes kinked it is likely resistance will be experienced while advancing the embolization coil through the kinked region.If the kink is severe enough the device may not be able to advance out of its sheath.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 in the inferior mesenteric artery (ima) using penumbra coil 400s (pc400s).During the procedure, the physician experienced resistance and was unable to advance a pc400 out of its introducer sheath and into the lantern delivery microcatheter (lantern), and therefore the pc400 was removed.The procedure was then completed using 6 additional pc400s 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: 7163086
• Report Number: 3005168196-2018-00013
• Device Sequence Number: 19279106
• 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): 12/06/2017

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: 09/28/2024
• Device Catalogue Number: 4002C0312
• Device Lot Number: F71843
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2017
• Initial Report FDA Received Date: 01/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR