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

Catalog Number	4006C0408
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/31/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the major aortopulmonary collateral artery (mapca) using penumbra coil 400s (pc400s).During the procedure, the physician successfully placed five pc400 coils in the target vessel using a lantern delivery microcatheter (lantern).While advancing a new pc400, the lantern kicked out of the target location; therefore, physician removed the pc400 in order to reposition the lantern.While retracting the pc400 into the lantern during an attempt to reposition, the pc400 unintentionally detached in the lantern.Therefore, the physician removed the lantern containing the detached coil, then removed the coil out and reinserted the lantern into the patient's body.The procedure was completed using additional pc400¿s and the same lantern.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the penumbra coil 400 (pc400) pusher assembly.Bends and kinks were present along the pusher assembly approximately 27.0, 107.0 and from 142.0 ¿ 147.5 cm from the proximal end.The embolization coil was detached from the pusher assembly distal detachment tip (ddt).The proximal constraint sphere was within the ddt.The stretch resistant (sr) wire within the embolization coil was fractured.Offset coil winds were present along the embolization coil.Conclusions: evaluation of the returned pc400 confirmed a detached embolization coil and revealed a fractured sr wire.If the device is forcefully retracted against resistance, damage such as a fractured sr wire may occur.This damage likely contributed to the reported unintentional detachment.The lantern identified in the complaint was not returned for evaluation.Further evaluation of the returned pc400 revealed pusher assembly kinks and offset coil winds.These damages were likely incidental to the reported complaint and may have occurred during packaging for return to penumbra.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.H3 other text : placeholder.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8775556
• Report Number: 3005168196-2019-01334
• Device Sequence Number: 1993412
• Product Code: HCG
• UDI-Device Identifier: 00814548011905
• UDI-Public: 00814548011905
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2019
• 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: 08/29/2026
• Device Catalogue Number: 4006C0408
• Device Lot Number: F85596
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/11/2019
• Supplement Date Received by Manufacturer: 07/19/2019
• Initial Report FDA Received Date: 07/10/2019
• Supplement Report FDA Received Date: 08/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 41 YR
• Date Report Sent to FDA: 01/01/2005