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

Catalog Number	4004C1030
Medical Device Problem Codes	Stretched (1601); Physical Resistance (2578); Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Results: the pc400¿s stretch resistant wire (sr wire) was fractured.There was no visible damage to the non-penumbra device.Conclusions: evaluation of the returned device revealed that the pc400¿s sr wire was fractured.This type of damage typically occurs due to improper handling during use.If the pc400 is forcefully retracted against resistance, damage such as this may occur.The root cause of the pc400 getting stuck inside the non-penumbra microcatheter could not be determined.The pc400 pusher assembly was not returned for evaluation.A stainless steel mandrel was advanced through the non-penumbra microcatheter and out of the distal tip without an issue.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 subclavian artery using penumbra coils 400 (pc400s).During the procedure, the physician placed a non-penumbra catheter in the left brachial artery, then advanced a non-penumbra microcatheter toward the treatment site.The physician then placed two non-penumbra coils and six pc400s in the target vessel.While attempting to advance a new pc400 through the microcatheter, the physician experienced resistance after advancing the pc400 halfway through the microcatheter.It was reported that the pc400 became stuck when it was slightly advanced out of the tip of the microcatheter and became unraveled in the microcatheter while being retracted.Therefore, the physician removed the microcatheter and the pc400 altogether.The pc400 was the removed and the microcatheter was reinserted into the patient¿s body.The procedure was completed using a new pc400 and the same microcatheter.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: 7129198
• Report Number: 3005168196-2017-02216
• Device Sequence Number: 11256494
• Product Code: HCG
• UDI-Device Identifier: 00814548010977
• UDI-Public: 00814548010977
• 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: 12/03/2024
• Device Catalogue Number: 4004C1030
• Device Lot Number: F72991
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2017
• 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