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

Catalog Number	4002C1040
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	05/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly of the penumbra coil 400 (pc400).The pusher assembly was fractured approximately 113.0 cm from the proximal end.The introducer sheath was kinked approximately 1.2 cm from the proximal end with the fractured pusher assembly inside.The embolization coil was intact with its pusher assembly and the coil windings were offset.Conclusions: evaluation of the first returned pc400 revealed that the pusher assembly was fractured.This type of damage typically occurs due to improper handling during use.If the device is forcefully advanced against resistance, damage such as this may occur.Further evaluation of the first evaluated pc400 revealed that the embolization coil windings were offset.This type of damage typically occurs due to improper handling during use.If a rotating hemostasis valve (rhv) is not used during insertion, the introducer sheath may not remain properly seated in the hub.If the introducer sheath is not properly seated inside the hub of the parent catheter prior to advancement, damage such as this may occur.The offset coil winding likely contributed to the resistance experienced during advancement into the px slim.Evaluation of the second returned pc400 revealed that the introducer sheath was stretched.This type of damage typically occurs due to improper handling during use.If the distal end of the introducer sheath is forcefully gripped, while attempting to remove the introducer sheath from the pusher assembly, damage such as this may occur.The stretched introducer sheath likely contributed to the introducer sheath not being able to be removed from the pusher assembly.The px slim mentioned in the complaint was not returned for evaluation.Penumbra coils are visually 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: 3005168196-2017-00967.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the internal iliac artery (iia) using penumbra coil 400''s (pc400''s).During the procedure, the physician advanced a px slim delivery microcatheter (px slim) into the target vessel and then attempted to advance a pc400 through it.However, while advancing the coil through its introducer sheath, the physician met resistance and was unable to advance the coil out of its introducer sheath and into the px slim delivery microcatheter (px slim).The pc400 was then removed and a new pc400 was opened and placed into the patient.Next, the physician advanced a new pc400 into the px slim but was unable to remove the coil''s introducer sheath from the proximal end of the pusher assembly.Therefore, the pc400 was removed and the procedure was completed using new pc400''s 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: 6662051
• Report Number: 3005168196-2017-00966
• Device Sequence Number: 10810019
• Product Code: HCG
• UDI-Device Identifier: 00814548010601
• UDI-Public: 00814548010601
• 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): 05/23/2017

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: 08/24/2024
• Device Catalogue Number: 4002C1040
• Device Lot Number: F71316
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2017
• Initial Report FDA Received Date: 06/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1