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

Catalog Number	4002C1857
Medical Device Problem Codes	Detachment Of Device Component (1104); Failure to Advance (2524)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/16/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Results: the pet lock on the proximal end of the penumbra coil 400 coil (pc400 coil) pusher assembly was intact.The coil was detached from the pusher assembly.The proximal constraint sphere was intact with the embolization coil.The pull wire was withdrawn and the pet lock was broken by the penumbra investigator for further evaluation.The distal end of the pc400 pusher assembly was dissected by the penumbra investigator in order to gain access to the pull wire.The outer diameters (od) of the proximal constraint sphere and pull wire, and the inner diameter (id) of the distal detachment tip (ddt) were measured to be within specification.Conclusions: evaluation of the returned device confirmed that the embolization coil was detached, and revealed that the pc400 did not sustain any gross damage.The proximal constraint sphere and the pull wire ods, as well as the ddt id were measured and found to be within specification.The observed unintentional detachment typically occurs due to improper handling during use.The initial complaint indicated that multiple attempts were made to withdraw the coil against resistance.If excessive force is used during withdrawal it is likely that the polymer portion of the pc400 will elongate, effectively extending the ddt distal to the reach of the pull wire distal end.This will allow the proximal constraint sphere of the embolization coil to become detached from the pusher assembly.These devices are 100% visually inspected and functionally tested during in-process inspection.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 splenic artery using penumbra coil 400 coils (pc400 coils).During the procedure, the physician deployed and detached four pc400 coils into the aneurysm using a px slim delivery microcatheter (px slim) and other manufacturers' devices.While advancing a fifth pc400 coil into the aneurysm, the physician felt an "entrapment" and was unable to advance the tip of the pc400 coil any further into the aneurysm.The physician then pulled back on the pc400 pusher assembly about ten times in an attempt to retract the pc400 coil from the px slim; however, the tip of the pc400 coil unintentionally detached.The px slim and the other manufacturers' devices were removed.The physician then reinserted the other manufacturer's sheath and required a snare device to retrieve the detached tip of pc400 coil.The procedure was successfully completed using eight new pc400 coils and the same px slim.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: 5378203
• Report Number: 3005168196-2016-00067
• Device Sequence Number: 332636
• 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: Physician
• Type of Report: Followup
• Report Date (Section B): 12/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 03/31/2020
• Device Catalogue Number: 4002C1857
• Device Lot Number: F63316
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/19/2016
• Supplement Report FDA Received Date: 03/03/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR