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

Catalog Number	4002C1660
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/15/2017
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 fractured approximately 5.0 cm from the proximal end and kinked in multiple locations throughout its length.The introducer sheath was kinked.The embolization coil was intact with the pusher assembly and had offset coil winds throughout its length.Conclusions: evaluation of the returned handle revealed it had no visible damage and was within functional specifications when tested.If the penumbra coil 400 (pc400) is placed in tortuous anatomy, friction can build up inside the hypotube of the pusher assembly, overcoming the force able to be applied by the handle, which can contribute to difficulty detaching the embolization coils.Evaluation of the returned pc400 revealed the introducer sheath was kinked and the pusher assembly was fractured.This damage was likely incidental and may have occurred during packaging for return to penumbra.The pc400 could not be advanced or retracted through the kinked introducer sheath; therefore, the pc400 could not be advanced into a microcatheter and be functionally tested for advancement out of the distal tip.Further evaluation revealed the pusher assembly was kinked and the embolization coil had offset coil winds.This type of damage typically occurs due to forceful advancement of the pc400 against resistance.The root cause of this initial resistance could not be determined.The px slim delivery microcatheter (px slim) and other (b)(4) mentioned in the complaint were not returned for evaluation.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.This report is associated with mfr report number: 3005168196-2017-02218.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the splenic artery using penumbra coil 400 detachment handles (handles) and penumbra coil 400s (pc400s).It was noted that the patient anatomy was tortuous.During the procedure, the physician deployed and detached two pod coils and pc400s in the target vessel using a px slim delivery microcatheter (px slim).After that, the physician advanced a new pc400 in the target vessel and attempted to detach it using the handle; however, the pc400 failed to detach.It was reported that the pet lock was separated about two millimeters.After several failed attempts, a new handle was opened and the pc400 was successfully detached.The physician continued the procedure by placing additional coils.While attempting to advance a new pc400 as the 27th coil through the px slim, the pc400 would not advance further after reaching almost the distal tip of the px slim.Therefore, it was removed, flushed with saline and re-inserted into the px slim; however, the same issue occurred.Therefore, the pc400 was removed and the procedure was completed using seven additional 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: 7129849
• Report Number: 3005168196-2017-02219
• Device Sequence Number: 11256577
• Product Code: HCG
• UDI-Device Identifier: 00814548010724
• UDI-Public: 00814548010724
• 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): 11/19/2017

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: 10/19/2024
• Device Catalogue Number: 4002C1660
• Device Lot Number: F72421
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2017
• Initial Report FDA Received Date: 12/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1