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

Catalog Number	4002C0925
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The embolization coil was detached from the pusher assembly.The embolization coil was fully intact with some offset coil winds.The pc400 pusher assembly was fractured approximately 4.5 cm and 18.0 cm from the proximal end of the pusher assembly.The distal fractured portion of the pusher assembly was not returned for evaluation.The pc400 embolization coil was detached and pusher assembly was fractured, therefore, functional analysis could not be performed.Conclusions: evaluation of the returned pc400 revealed a detached embolization coil and fractured pusher assembly.A pusher assembly typically fractures as a result of manipulation against resistance.If the pusher assembly is forcefully advanced against resistance it may become kinked or fractured.If a kinked pusher assembly is further manipulated it may worsen to eventual fracture.When the pusher assembly fractures, it will likely result in the pull wire retracting from the distal detachment tip (ddt) allowing the embolization coil to detach.The non-penumbra microcatheter identified in the complaint was not returned for evaluation; therefore, the root cause of the pusher assembly becoming fractured could not be determined.Evaluation of the returned embolization coil revealed it was detached with some offset coil winds.These coil winds may have been a result of multiple attempts to place the coil.The proximal constraint sphere was intact with the embolization coil further supporting the coil detachment occurred due to pusher assembly fracture.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 subclavian artery using penumbra coils 400 (pc400s).During the procedure, after deploying a pc400 into the target vessel using a lantern delivery microcatheter (lantern), the physician advanced and retracted the pc400 several times for repositioning; however, when retracting the pc400, it unintentionally detached inside the lantern.Therefore, the physician withdrew the lantern containing the detached pc400 and flushed the coil out.The procedure was completed using three other 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: 8014963
• Report Number: 3005168196-2018-02150
• Device Sequence Number: 1380326
• Product Code: HCG
• UDI-Device Identifier: 00814548010571
• UDI-Public: 00814548010571
• Combination Product (Y/N): Y
• 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): 09/27/2018
• Report Date (Section F): 01/01/2005

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: Health Professional
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: 4002C0925
• Device Lot Number: F33326
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2018
• Initial Report FDA Received Date: 10/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Date Report Sent to FDA: 01/01/2005