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

Catalog Number	4002C0312
Medical Device Problem Codes	Physical Resistance (2578); Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.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 left internal iliac artery (iia) to treat type ii endoleak using penumbra coils 400 (pc400s).It was reported that the patient anatomy was mildly tortuous.During the procedure, the physician placed two non-penumbra coils and one pc400 in the target vessel using a non-penumbra microcatheter.While attempting to advance a new pc400 through the microcatheter, the physician experienced resistance right after inserting the pc400 into the microcatheter and the pc400 became stuck; therefore it was removed.The procedure was completed using another coil and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the embolization coil was intact with the pusher assembly and had offset coil winds throughout its length conclusions: evaluation of the returned device revealed the embolization coil had offset coil winds.This type of damage typically occurs due to forceful manipulation of the pc400 against resistance.The offset coil winds caused resistance when resheathing and advancing the pc400 through its introducer sheath.The root cause of the initial resistance experienced during the procedure could not be determined.The non-penumbra microcatheter mentioned in the complaint was 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.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7149453
• Report Number: 3005168196-2017-02287
• Device Sequence Number: 11040053
• Product Code: HCG
• UDI-Device Identifier: 00814548013367
• UDI-Public: 00814548013367
• 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,Followup
• Report Date (Section B): 11/28/2017

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: 08/15/2024
• Device Catalogue Number: 4002C0312
• Device Lot Number: F71146
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/28/2017
• Supplement Date Received by Manufacturer: 01/24/2018
• Initial Report FDA Received Date: 12/27/2017
• Supplement Report FDA Received Date: 02/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1