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

Catalog Number	4002C1450
Medical Device Problem Codes	Kinked (1339); Failure to Advance (2524); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was fractured approximately 48.6 cm from the proximal end.The embolization coil was detached from its pusher assembly.Conclusions: evaluation of the returned device revealed that the pc400¿s pusher assembly was fractured.This type of damaged typically occurs due to improper handling during use.If the device is forcefully advanced against resistance as was mentioned in the complaint, damage such as a kink may occur.Then, if the kink is attempted to be straightened, damage such as a fracture may occur.If the pusher assembly becomes fractured, it may allow the pull wire to retract out of the distal detachment tip, which would allow the embolization coil to detach.The root cause of the initial resistance experienced prior to forceful advancement could not be determined.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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the left internal iliac artery (iia) using penumbra coil 400s (pc400s).During the procedure, the physician successfully deployed and detached five pc400s in the target vessel using a px slim delivery microcatheter (px slim).While attempting to advance another pc400 through the px slim, the physician experienced resistance and the pc400 was unable to advance any further.The physician then attempted to forcefully advance the pc400 coil through the middle of the px slim and consequently, the pc400 pusher wire became kinked.Therefore, the physician removed the px slim with the pc400 inside, and then removed the pc400 from the px slim.The procedure was completed using the same px slim and additional pc400s.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: 6985116
• Report Number: 3005168196-2017-01902
• Device Sequence Number: 13760031
• Product Code: HCG
• UDI-Device Identifier: 00814548010687
• UDI-Public: 00814548010687
• 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): 10/04/2017

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: 4002C1450
• Device Lot Number: F71319
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2017
• Initial Report FDA Received Date: 10/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR